FDA.reportPublic FDA data

PRIMO

Primary DI
00840216113398
Brand
PRIMO
Company
ASP GLOBAL, LLC
Model
AB201XXL
Device description
Abdominal Binder - 2XLarge (73"-80")
Published
2022-04-06
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

Product Codes#

Code, Name table
CodeName
FSDBinder, Abdominal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSDBinder, AbdominalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840216113398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216113398008402161133988402161133980840216113398

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal binder, reusableA strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a reusable device.

Sterilization Methods#

Method table
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975740361312MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361336MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361343MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361565MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361572MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361589MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361596MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361602MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361619MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361626MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361633MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361640MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361657MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361664MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361671MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361688MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361978MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361985MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361992MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740362005MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740362173MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740362180MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-28
06975740362197MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-28
06975740362203MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-28
00190446660217PROCAREDJO, LLCFSD2025-05-14
00190446660279PROCAREDJO, LLCFSD2025-05-14
00190446660286PROCAREDJO, LLCFSD2025-05-14
00190446660293PROCAREDJO, LLCFSD2025-05-14
00190446660750PROCAREDJO, LLCFSD2025-05-14
00190446660767PROCAREDJO, LLCFSD2025-05-14