FDA.reportPublic FDA data

Unistik VacuFlip

Primary DI
00384707102015
Brand
Unistik VacuFlip
Company
OWEN MUMFORD USA INCORPORATED
Model
BC 7102
Device description
"Unistik VacuFlip, 21G safety needle 1"" with holder"
Published
2023-10-06
Public version status
New
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
FMINeedle, Hypodermic, Single Lumen
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223854000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223854000Unistik® ShieldLock, Unistik VacuFlipOwen Mumford, Ltd.2023-06-30JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00384707102039PackageGS1600In Commercial Distribution
00384707102015PrimaryGS10
00384707102008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384707102039003847071020393847071020390384707102039
00384707102015003847071020153847071020150384707102015
00384707102008003847071020083847071020080384707102008

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Regulatory Flags#

DUNS number
803401454
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00761059352914Unifine PentipsAN 3529AC2024-01-22
00761059354000Unifine PentipsAN 3540AC2024-02-05
00761059359012Unifine PentipsAN 3590AC2024-02-21
00761059507093Unifine PentipsAN 3550AC2024-05-17
00384701604010Unistik Pro PlusAT 16042025-09-16
00384703160019EmpelvicSM 31602025-08-22
00384703150010EmpelvicSM 31502025-08-22
00384703155015EmpelvicSM 31552025-08-22
00761059640004Unifine OTCAN 36402025-02-14
00761059641001Unifine OTCAN 36412025-02-14
00761059650003Unifine OTCAN 36502025-02-14
00761059651000Unifine OTCAN 36512025-02-14
00761059640028Unifine OTCAN 36402025-02-14
00761059641032Unifine OTCAN 36412025-02-14
00761059650027Unifine OTCAN 36502025-02-14
00761059651031Unifine OTCAN 36512025-02-14
00761059354024Unifine PentipsAN 3540AC2024-02-05
00761059352921Unifine PentipsAN 3529AC2024-01-22
00384707001011Unistik VacuFlipBC 70012023-10-06
00384707117019Unistik ShieldLockWS 71172023-10-06

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