FDA.reportPublic FDA data

Unolok

Primary DI
08903347003289
Brand
Unolok
Company
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
Model
"23 G X ¾"""
Catalog number
00328
Device description
"UNOLOK Luer Lock Infusion Sets,23 G X ¾"" (0.60 X19MM ) 12"" TUBE MYCO RE-ORDER # 7001-23"
Published
2017-01-09
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

Product Codes#

Code, Name table
CodeName
FOZCatheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953252000DISPOSABLE SCALP VEIN INFUSION SETMyco Medical Supplies, Inc.1996-11-26FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18903347003286PackageGS1100In Commercial Distribution
28903347003283PackageGS110In Commercial Distribution
58903347003284PackageGS118In Commercial Distribution
08903347003289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1890334700328618903347003286
2890334700328328903347003283
5890334700328458903347003284
08903347003289089033470032898903347003289

GMDN Terms#

Term, Definition table
TermDefinition
Venous butterfly needle/setAn invasive device/collection of devices which includes a sharp and rigid needle intended to puncture a vein to collect blood and/or for transient (<24 hours) administration of intravenous (IV) fluids. The needle includes wings for fixation/placement and may include tubing/connectors; it is not, and does not include, a peripheral catheter. The device may be referred to as a butterfly needle or scalp vein needle. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
862318107
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
08903347051891UNOLOK3ml (22G x 1 1/2'')051892024-06-25
18903347051898UNOLOK3ml (22G x 1 1/2'')051892024-06-25
08903347023461Vaku-8"23 G X ¾"""023462017-01-09
08903347023478Vaku-8"25 G X ¾"""023472017-01-09
08903347002336UNOLOK+"19 G X ¾"""002332017-04-26
08903347002343UNOLOK+ "21 G X ¾"""002342017-04-26
08903347002350UNOLOK+ "23G X ¾"""002352017-04-26
08903347002367UNOLOK+ "25G X ¾"""002362017-04-26
08903347003241UNOLOK"19 G X ¾"""003242017-04-26
08903347003265UNOLOK "21 G X ¾"""003262017-04-26
08903347003272UNOLOK"22G X ¾"""003272017-04-26
08903347003302Unolok"25 G X ¾"""003302017-01-09
08903347023423VAKU-8+ "21 G X ¾"""023422017-04-26
08903347023430VAKU-8+ "23G X ¾"""023432017-04-26
08903347023447VAKU-8+ "25G X ¾"""023442017-04-26
08903347023454Vaku-8"21 G X ¾"""023452017-01-09
08903347034696VAKU-8 "22G X 3/4"""034692017-04-26
18903347023468Vaku-823 G X ¾"023462017-01-09
18903347023475Vaku-825 G X ¾"023472017-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00382903935314NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
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00382903935338NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
10801902167344ARROWTELEFLEX INCORPORATEDFOZ2026-07-30
10801902129700ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902167351ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902167894ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902226379ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226386ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
00850073657003Ruby Intravascular CatheterVenocare, Inc.FOZ2026-04-08
10884521832930MAHURKARMozarc Medical US LLCFOZ2022-11-03
10884521832985MAHURKARMozarc Medical US LLCFOZ2022-11-03
08032248007123SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007130SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007147SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007154SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007161SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007178SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007185SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007192SOL CARE T DELTA MED SPAFOZ2021-03-30