FDA.reportPublic FDA data

UNOLOK+

Primary DI
08903347002343
Brand
UNOLOK+
Company
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
Model
"21 G X ¾"""
Catalog number
00234
Device description
"UNOLOK+ Luer Lock Infusion Set,21 G X ¾"" ( 0.80X19MM) 7"" TUBE MYCO RE-ORDER # 7001P-21L"
Published
2017-04-26
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
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000592000UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SETMyco Medical Supplies, Inc.2001-04-12FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18903347002340PackageGS1100In Commercial Distribution
28903347002347PackageGS110In Commercial Distribution
58903347002348PackageGS114In Commercial Distribution
08903347002343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1890334700234018903347002340
2890334700234728903347002347
5890334700234858903347002348
08903347002343089033470023438903347002343

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
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
08903347003289Unolok"23 G X ¾"""003282017-01-09
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

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Primary DI, Brand, Company table
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