IMPORTANT NOTE: These technical specifications are generic and may vary among suppliers.
Product Description :
A portable device used by a patient or a person with a disability that is confined to his/her bed as a receptacle in which to urinate and/or defecate. It will be removed and emptied by attending staff and sanitized for reuse. This is a reusable device.
Technical specifications
• Material: Stainless steel
• Model
o to be slipped (sloping front)
o anatomical shape, to fit the body
o all edges should be rounded and surfaces should be smooth
o one-piece moulding with no seams or joints, no internal edges where bacteria can hide and multiply
• With one handle in the back
• With Lid : Make sure the lid is secure but also easy to remove.
• Weight tolerance: for adults weighing 25 kg - 160 kg
• Dimensions: ± 45 x 28 x 4 cm
• Volume ± 2.5 l
SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish.
Packaging and labelling:
Unit presentation: non-sterile, multiple-use, size and manufacture's name.
Packaging: Protected in a plastic bag, single units.
Labelling of the primary packaging displays, at least: Product name, size, reference number, manufacturer's name and address, CE mark or similar, lot number or batch number, UDI (if MDR followed), use-by-date, symbol for Medical device.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol), if applicable.
Symbols used according ISO 15223
CE Mark
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
Note : For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year.
OR US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Safety & product Standards:
BS 2588-1, 1992, Portable sanitary pans for use in healthcare establishments. Specification for reusable bed pans
Product Description :
A portable device used by a patient or a person with a disability that is confined to his/her bed as a receptacle in which to urinate and/or defecate. It will be removed and emptied by attending staff and sanitized for reuse. This is a reusable device.
Technical specifications
• Material: Stainless steel
• Model
o to be slipped (sloping front)
o anatomical shape, to fit the body
o all edges should be rounded and surfaces should be smooth
o one-piece moulding with no seams or joints, no internal edges where bacteria can hide and multiply
• With one handle in the back
• With Lid : Make sure the lid is secure but also easy to remove.
• Weight tolerance: for adults weighing 25 kg - 160 kg
• Dimensions: ± 45 x 28 x 4 cm
• Volume ± 2.5 l
SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish.
Packaging and labelling:
Unit presentation: non-sterile, multiple-use, size and manufacture's name.
Packaging: Protected in a plastic bag, single units.
Labelling of the primary packaging displays, at least: Product name, size, reference number, manufacturer's name and address, CE mark or similar, lot number or batch number, UDI (if MDR followed), use-by-date, symbol for Medical device.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol), if applicable.
Symbols used according ISO 15223
CE Mark
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
Note : For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year.
OR US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Safety & product Standards:
BS 2588-1, 1992, Portable sanitary pans for use in healthcare establishments. Specification for reusable bed pans
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $25.00 |
