FDA.reportPublic FDA data

"VACSURE SAFETY MULTI-SAMPLE NEEDLE22G X 1 1/4"", W/ PREMOUNTED HOLDER"

Primary DI
00850014448035
Brand
"VACSURE SAFETY MULTI-SAMPLE NEEDLE22G X 1 1/4"", W/ PREMOUNTED HOLDER"
Company
LABOTEK GROUP CORP
Model
VM-1022-AH
Catalog number
VM-1022-AH
Device description
"SAFETY MULTI-SAMPLE NEEDLE22G X 1 1/4"", W/ PREMOUNTED HOLDER"
Published
2021-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850014448032PackageGS150In Commercial Distribution
20850014448039PackageGS110In Commercial Distribution
00850014448035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001444803210850014448032
2085001444803920850014448039
00850014448035008500144480358500144480350850014448035

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7864739436LBORGES@LABOTEKGROUP.COM

Regulatory Flags#

DUNS number
117338398
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
00850014448141VACSURE Uni-BandRR-1512024-03-18
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

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