FDA.report

NA

Primary DI
00842307102472
Brand
NA
Company
GENDRON, INC.
Model
1150-123-214-122
Device description
STRETCHER,CHR FRM,ENAM LTR
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
FPOStretcher, Wheeled

Product Code Classifications

CodeDeviceSpecialtyClass
FPOStretcher, WheeledGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842307102472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842307102472008423071024728423071024720842307102472

GMDN Terms

TermDefinition
Hospital stretcher, manualA manually-operated device consisting of a platform mounted on a wheeled frame designed primarily to facilitate easy transport of a recumbent patient within a healthcare facility; it may include side rails, supports for fluid infusion equipment, and patient securement straps. The device may also be used as a treatment table (e.g., in an emergency, recovery, or labour room), or as a bed in some intensive and specialized care units or under high patient census conditions (e.g., disasters).

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
false
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
00842307100065NA3150-4043-62016-09-23
00842307100072NA3642HC2016-09-23
00842307100096NA36482016-09-23
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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