DEVICE: UNOLOK+ (08903347002343)

Device Identifier (DI) Information

UNOLOK+
21 G X ¾"
In Commercial Distribution
00234
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
08903347002343
GS1

1
862318107 *Terms of Use
UNOLOK+ Luer Lock Infusion Set,21 G X ¾" ( 0.80X19MM) 7" TUBE MYCO RE-ORDER # 7001P-21L
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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
FPA Set, Administration, Intravascular
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K000592 000
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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

a74e5ac2-ea63-4d21-874e-292d08399202
July 23, 2020
5
April 26, 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
18903347002340 100 08903347002343 In Commercial Distribution BOX
28903347002347 10 18903347002340 In Commercial Distribution CARTON
58903347002348 14 28903347002347 In Commercial Distribution PALLET
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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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