FDA.reportPublic FDA data

U-Sling without Head Support - Large

Primary DI
00840117300248
Brand
U-Sling without Head Support - Large
Company
Dynarex Corporation
Model
10744LG
Published
2019-12-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSALift, Patient, Non-Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117300248PrimaryGS10
00616784074436Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117300248008401173002488401173002480840117300248
00616784074436006167840744366167840744360616784074436

GMDN Terms#

Term, Definition table
TermDefinition
Mobile solid seat lifting system seatA lifting device used together with a mobile solid seat lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position for transfer and (re)positioning. It is designed as a seat with a solid surface (this may be padded) upon which the person to be lifted is sat and contained during the lifting process.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784711720Disposable Ear Specula Tips For Diagnostic Otoscopes, Adult, 4.25 mm71172021-05-21
00616784418025Bandage Shears 7.5" (19.1 cm) Black41802020-11-08
00616784418124Bandage Shears 7.5" (19.1 cm) Blue41812020-11-08
00616784418223Bandage Shears 7.5" (19.1 cm) Magenta41822020-11-08
00616784418322Bandage Shears 7.5" (19.1 cm) Orange41832020-11-08
00616784418421Bandage Shears 7.5" (19.1 cm) Purple41842020-11-08
00616784418520Bandage Shears 7.5" (19.1 cm) Red41852020-11-08
00616784418629Bandage Shears 7.5" (19.1 cm) Teal41862020-11-08
00616784418728Bandage Shears 7.5" (19.1 cm) Yellow41872020-11-08
00616784419022Mini Scissors 4" (10.2 cm) Red41902020-11-08
00616784419121Bandage Shears 5.5" (14.0 cm) Black41912020-11-08
00616784419220Bandage Shears 5.5" (14.0 cm) Blue41922020-11-08
00616784419329Bandage Shears 5.5" (14.0 cm) Magenta41932020-11-08
00616784419428Bandage Shears, 5.5" (14.0 cm) Orange41942020-11-08
00616784419527Bandage Shears 5.5" (14.0 cm) Purple41952020-11-08
00616784419626Bandage Shears, 5.5" (14.0 cm) Red41962020-11-08
00616784419725Bandage Shears, 5.5" (14.0 cm) Teal41972020-11-08
00616784419824Bandage Shears,5.5" (14.0 cm) Yellow41982020-11-08
00616784711522PA SensiLance Pressure Activated Safety Lancets,Sterile71152021-05-21
00616784711621Disposable Ear Specula Tips, For Diagnostic Otoscopes, 2.5 mm, Pediatric71162021-05-21

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Primary DI, Brand, Company table
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