FDA.reportPublic FDA data

Vaku-8

Primary DI
18903347023475
Brand
Vaku-8
Company
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
Model
25 G X ¾"
Catalog number
02347
Device description
VAKU-8 Blood Collection Set, 25G X ¾" (0.50X19MM) 12" TUBE MYCO REORDER # SVMS-25A
Published
2017-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
18903347023475PackageGS1100In Commercial Distribution
28903347023472PackageGS110In Commercial Distribution
58903347023473PackageGS118In Commercial Distribution
08903347023478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1890334702347518903347023475
2890334702347228903347023472
5890334702347358903347023473
08903347023478089033470234788903347023478

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
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

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
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

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Primary DI, Brand, Company table
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00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
00616784894027LabChoice SecureSafety Safety Blood Collection Sets, Sterile,Dynarex CorporationFPA2018-05-26
00616784894126LabChoice SecureSafety Safety Blood Collection Sets, SterileDynarex CorporationFPA2018-05-26