FDA.reportPublic FDA data

Kurin Blood Collection Set, 23 Ga, Push Button Needle, BD Vacutainer

Primary DI
20851682007078
Brand
Kurin Blood Collection Set, 23 Ga, Push Button Needle, BD Vacutainer
Company
PATHWAY, LLC
Model
D-21223
Published
2017-03-13
Public version status
Update
Distribution status
Not 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
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851682007071PackageGS150Not in Commercial Distribution
20851682007078PackageGS14Not in Commercial Distribution
00851682007074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085168200707110851682007071
2085168200707820851682007078
00851682007074008516820070748516820070740851682007074

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
080312381
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
00851682007562Cooler Heads8307712022-11-07
00860009140509UpLyftST-1202023-08-08
00851682007005Kurin Blood Collection Set, 21 Ga, BioMerieuxM-112212017-03-13
00851682007012Kurin Blood Collection Set, 23 Ga, BD BioMerieuxM-112232017-03-13
00851682007036Kurin Blood Collection Set, 21 Ga, BD VacutainerD-112212017-03-13
00851682007067Kurin Blood Collection Set, 23 Ga, Push Button Needle, BioMerieuxM-212232017-03-13
00851682007074Kurin Blood Collection Set, 23 Ga, Push Button Needle, BD VacutainerD-212232017-03-13
00851682007081Kurin Blood Collection Set, 21 Ga, Push Button Needle, BioMerieux ShieldM-212212017-03-13
00851682007104Kurin Blood Collection Set, 21 Ga, Push Button Needle, BD VacutainerD-212212017-03-13
20851682007009Kurin Blood Collection Set, 21 Ga, BioMerieuxM-112212017-03-13
20851682007016Kurin Blood Collection Set, 23 Ga, BD BioMerieuxM-112232017-03-13
20851682007030Kurin Blood Collection Set, 21 Ga, BD VacutainerD-112212017-03-13
20851682007061Kurin Blood Collection Set, 23 Ga, Push Button Needle, BioMerieuxM-212232017-03-13
00851682007043Kurin Blood Collection Set, 23 Ga, BD VacutainerD-112232017-03-13
20851682007047Kurin Blood Collection Set, 23 Ga, BD VacutainerD-112232017-03-13

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Primary DIBrandCompanyProduct codePublished
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08586015044786CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
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08586015044816CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
10197344019649MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-23
10197344039715MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-17
10197344039708MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-16
10197344132911MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
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10850074089060SurgycoSurgyco LLCJKA2025-12-23
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10850074089084SurgycoSurgyco LLCJKA2025-12-23
10850074089091SurgycoSurgyco LLCJKA2025-12-23
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10850074089114SurgycoSurgyco LLCJKA2025-12-23
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10612479275727McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275758McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275789McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14