FDA.reportPublic FDA data

BIOS Living

Primary DI
00057475210229
Brand
BIOS Living
Company
Thermor Ltd
Model
LK022
Device description
Latex Finger Cots, Box of 144 medium sized
Published
2023-09-18
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
10057475210226PackageGS16In Commercial Distribution
20057475210223PackageGS16In Commercial Distribution
00057475210229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747521022610057475210226
2005747521022320057475210223
00057475210229000574752102290574752102290057475210229

GMDN Terms#

Term, Definition table
TermDefinition
Finger-stallA device intended to be worn on an examiner's finger to prevent contamination between patient and examiner. This is a single-use device.

Regulatory Flags#

DUNS number
246883458
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00057475032500BIOS DiagnosticsW2502026-01-19
00057475491505BIOS DiagnosticsNS1502026-01-19
20057475032504BIOS DiagnosticsW2502026-01-19
00057475242909BIOS DiagnosticsBD2902026-01-19
10057475491502BIOS DiagnosticsNS1502026-01-19
00057475820213BIOS LivingRL0212026-01-19
00057475220495BIOS Diagnostics220DI2023-09-20
00057475282493BIOS282DI2023-05-23
00057475282738BIOS LivingLH2732024-03-21
00057475282745BIOS LivingLH2742024-03-21
00057475561017BIOS LivingEP1012024-03-22
00057475561024BIOS LivingEP1022024-03-22
00057475561031BIOS LivingEP1032024-03-23
00057475561048BIOS LivingEP1042024-03-23
00057475561055BIOS LivingEP1052024-03-22
00057475561062BIOS LivingEP1062024-03-22
00057475561079BIOS LivingEP1072024-03-22
00057475561086BIOS LivingEP1082024-03-22
00057475561093BIOS LivingEP1092024-03-22
00057475561222BIOS LivingEP1222024-03-22

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
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
00814889010193Front LineProstat First Aid, LLCLZB2022-10-27
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