FDA.report

NA

Primary DI
00842307101741
Brand
NA
Company
GENDRON, INC.
Model
5148PDX-G
Device description
BED, BARIATRIC ACUTE CARE 5 FUNCTION, 1000 LB CAPACITY,48" DECK WIDTH, INCLUDESPOWER FIFTH WHEEL DRIVEAND PULLOUT EDGE GUARDS
Published
2017-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications

CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842307101741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842307101741008423071017418423071017410842307101741

GMDN Terms

TermDefinition
Bariatric bedA mains electricity (AC-powered) bed specifically designed as a bed to accommodate a bariatric (obese) patient whose body mass exceeds the safe working load of standard hospital/institution beds and trolleys, i.e., 500 kg total, including the weight of the mattress and other accessories. Features like size, shape, and patient comfort (both physical and mental) will be taken into consideration by the design. This device is electrically-operated to assist the user/attending staff to adjust the functions and positions of the bed. It will typically include adjustable height, back rest, knee-break, removable head and foot ends and possibly an integrated weighing facility.

Sterilization Methods

Method

Regulatory Flags

DUNS number
054164587
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00842307100027NA11502016-09-23
00842307100034NA1150-123-213-1402016-09-23
00842307100041NA1190-1322016-09-23
00842307100058NA16002016-09-23
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00842307100072NA3642HC2016-09-23
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00842307100102NA4000MRQ22016-09-23
00842307100119NA4748SB2016-09-23
00842307100126NA5154DX-12016-09-23
00842307100133NA5154PDX2016-09-23
00842307100140NA5322-18-62-36-P11882016-09-23
00842307100157NA5324-18-61-36-P11882016-09-23
00842307100164NA5424-18-61-36-P11882016-09-23
00842307100171NA6324-18-61-78-36-8-P11882016-09-23
00842307100188NA6424-18-61-78-36-8-P11882016-09-23
00842307100195NA6724-18-61-78-29-82016-09-23
00842307100201NA6724-18-62-78-28-82016-09-23

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