DEVICE: Kurin Blood Collection Set, 21 Ga, BioMerieux (00851682007005)

Device Identifier (DI) Information

Kurin Blood Collection Set, 21 Ga, BioMerieux
M-11221
Not in Commercial Distribution

PATHWAY, LLC
00851682007005
GS1
July 23, 2018
1
080312381 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58490 Venous butterfly needle/set
An invasive, hollow, tubular, metal device intended to puncture a vein to collect blood and/or for transient (<24 hours) or short-term (<= 30 days) administration of intravenous (IV) fluids. It includes wings for fixation/placement and may include tubing and/or connectors; however, it does not include accessories to facilitate introduction (e.g., stylet). The device may also be referred to as butterfly needle or scalp vein needle. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

b817e333-49e1-4283-bdaf-3e2480b2ab59
July 23, 2020
5
March 13, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20851682007009 4 10851682007002 2018-07-23 Not in Commercial Distribution
10851682007002 50 00851682007005 2018-07-23 Not in Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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