FDA.reportPublic FDA data

VACSURE Uni-Band

Primary DI
00850014448141
Brand
VACSURE Uni-Band
Company
LABOTEK GROUP CORP
Model
RR-151
Device description
VACSURE Uni-Band, Universal bandage, 28 x 15 mm pad size, 19 x 38 mm overall size, Individually wrapped
Published
2024-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014448141PackageGS1100In Commercial Distribution
10850014448148PackageGS160In Commercial Distribution
00850014448134PrimaryGS10
10850014448131Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014448141008500144481418500144481410850014448141
1085001444814810850014448148
00850014448134008500144481348500144481340850014448134
1085001444813110850014448131

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28Millimeter
Width15Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7877851555e.colon@labotekgroup.com

Regulatory Flags#

DUNS number
117338398
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00850014448424VacSure EZ Care Pressure Activate Safety LancetVEZC-30152024-12-03
00850014448431VacSure EZ Care Pressure Activate Safety LancetVEZC-30152024-12-03
00850014448462VacSure EZ Care Pressure Activate Safety LancetVEZC-21222024-12-03
00850014448332VACSURE Disposable TourniquetsVS-DTD2024-03-18
00850014448134VACSURE Uni-BandRR-1512024-03-18
00850014448158Labotek Spot BandageRR-1502024-03-18
00850014448172TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-XS2024-03-18
00850014448196TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-S2024-03-18
00850014448219TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-M2024-03-18
00850014448233TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-L2024-03-18
00850014448257TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-XL2024-03-18
00850014448349VACSURE Sharp ContainerRRI-1QT2024-03-18
00850014448356VACSURE Sharp ContainerRRI-5QT2024-03-18
00850014448363VACSURE Sharp ContainerRRI-2GAL2024-03-18
00850014448370VACSURE Sharp ContainerRRI-3GAL-S2024-03-18
00850014448387VACSURE Sharp ContainerRRI-8GAL2024-03-18
00850014448165Labotek Spot BandageRR-1502024-03-18
00850014448189TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-XS2024-03-18
00850014448202TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-S2024-03-18
00850014448226TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-M2024-03-18

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Primary DI, Brand, Company table
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00850087488389CeeportCEEPORT INC.KGX2026-05-29
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00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27
10197344102716MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102723MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102730MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102747MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20