FDA.reportPublic FDA data

Front Line

Primary DI
00814889010193
Brand
Front Line
Company
Prostat First Aid, LLC
Model
2412
Device description
FINGER COTS MD BLUE
Published
2022-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZBFinger Cot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZBFinger CotGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814889010193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814889010193008148890101938148890101930814889010193

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Regulatory Flags#

DUNS number
117129815
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814889016782ProStat70422026-05-08
00814889016492ProStat0164072025-09-03
00814889010599ProStat25922025-07-02
00814889010605ProStat20422025-07-02
00814889010629ProStat22792025-07-02
00814889010131ProStat20082022-10-27
00814889010643ProStat22062022-10-27
00814889010698ProStat20382022-10-27
00814889010803ProStat21952022-10-27
00814889010810ProStat21982022-10-27
00814889010827ProStat21962022-10-27
00814889010834ProStat21942022-10-27
00814889010841ProStat21972022-10-27
00814889016348ProStat20962025-02-24
00814889016355ProStat21482025-02-24
00814889016362ProStat22942025-02-24
00814889014771Front LineFL20082023-11-03
00814889016331ProStat20822025-02-24
00814889016379ProStat20252025-02-24
00814889010865ProStat22702024-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810208581761NuCareNuCare LLCLZB2026-02-04
10810208581778NuCareNuCare LLCLZB2026-02-04
10810208581785NuCareNuCare LLCLZB2026-02-04
10810208581792NuCareNuCare LLCLZB2026-02-04
10810208581808NuCareNuCare LLCLZB2026-02-04
10884389105214MedlineMEDLINE INDUSTRIES, INC.LZB2024-03-05
40884389105215MedlineMEDLINE INDUSTRIES, INC.LZB2024-03-05
00057475210229BIOS LivingThermor LtdLZB2023-09-18
20057475210223BIOS LivingThermor LtdLZB2023-09-18
10665973017898Tech-MedDukal LLCLZB2022-12-09
10665973017904Tech-MedDukal LLCLZB2022-12-09
10665973017911Tech-MedDukal LLCLZB2022-12-09
10665973017928Tech-MedDukal LLCLZB2022-12-09
10665973023660Tech-MedDukal LLCLZB2022-12-06
10665973023677Tech-MedDukal LLCLZB2022-12-06
10665973023684Tech-MedDukal LLCLZB2022-12-06
10665973023691Tech-MedDukal LLCLZB2022-12-06
20665973023667Tech-MedDukal LLCLZB2022-12-06
20665973023674Tech-MedDukal LLCLZB2022-12-06
20665973023681Tech-MedDukal LLCLZB2022-12-06
20665973023698Tech-MedDukal LLCLZB2022-12-06
00814889010377Front LineProstat First Aid, LLCLZB2022-10-28
00814889013781Front LineProstat First Aid, LLCLZB2022-10-28
00814889014153Front LineProstat First Aid, LLCLZB2022-10-28
00814889014160Front LineProstat First Aid, LLCLZB2022-10-28
00814889014207Front LineProstat First Aid, LLCLZB2022-10-28
00814889010209Front LineProstat First Aid, LLCLZB2022-10-27
00814889013798Front LineProstat First Aid, LLCLZB2022-10-27
00073577903777First Aid OnlyAcme United CorporationLZB2022-01-22
00092265060509First Aid OnlyAcme United CorporationLZB2022-01-22