FDA.report

PRIMO

Primary DI
00840216113206
Brand
PRIMO
Company
ASP GLOBAL, LLC
Model
GGTS06
Device description
G&G BARIATRIC ANGLED BUNDLE; 1 EACH - 36" X 60" TURN SHEET & 2 EACH - 15" LONG ANGLED WEDGES
Published
2022-03-18
Public version status
New
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
FMPProtector, Skin Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840216113206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216113206008402161132068402161132060840216113206

GMDN Terms

TermDefinition
Patient transfer/turning sheetA manual device in the form of a sturdy sheet intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080361159
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840216128262ASP GLOBALEGT3052025-11-20
00840216128286ASP GLOBALEGT3072025-11-20
00840216128804ASP GLOBAL PRIMOAFTS012025-06-30
00840216128279ASP GLOBALEGT3062025-06-17
00840216128293ASP GLOBALEGT3082025-06-17
00840216128842CARDINAL HEALTH AD6X10BILH2025-06-17
00840216128606LAPCORP LC4X6EZQ2025-05-13
00840216128613LAPCORP LC9X12MTL2025-05-13
00840216128163QUEST DIAGNOSTICSQD6.75X11AD2024-11-22
00840216127753ASP MEDICALMRT8002024-09-12
00840216128033ASP MEDICALMRACUP12024-09-12
20840216127566PRIMOAFTMATT2024-08-12
00840216120808PRIMOGGS3660TBH-K2024-03-05
00840216120853PRIMOGGS5670TBH-K2024-03-05
00840216121898PRIMOGGTS142024-03-05
00840216124509PRIMOGGTS13-K2024-03-05
00840216124516PRIMOGGTS14-5-K2024-03-05
00840216122697PRIMOAFPUMP2024-03-01
00840216125124PRIMOHB2002024-03-01
00840216125131PRIMOHB200B2024-03-01

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