DEVICE: Unolok (08903347003302)

Device Identifier (DI) Information

Unolok
25 G X ¾"
In Commercial Distribution
00330
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
08903347003302
GS1

1
862318107 *Terms of Use
UNOLOK Luer Lock Infusion Sets,25 G X ¾" ( 0.50X19MM) 12" TUBE MYCO RE-ORDER # 7001-25
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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
FOZ Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K953252 000
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

4481bf8b-aa07-47ec-b35c-c0c0435dafe6
July 23, 2020
5
January 09, 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
18903347003309 100 08903347003302 In Commercial Distribution BOX
28903347003306 10 18903347003309 In Commercial Distribution Carton
58903347003307 18 28903347003306 In Commercial Distribution Palet
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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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