DEVICE: Omnifix® (04046964941153)

Device Identifier (DI) Information

Omnifix®
339165
In Commercial Distribution
339165
B. BRAUN MEDICAL INC.
04046964941153
GS1

25
002397347 *Terms of Use
PS5LFN 5ML SYR & FILTER NDL SET NRFIT
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Epidural/intrathecal anaesthesia kit A collection of sterile devices designed to deliver an analgesic or anaesthetic agent into the epidural and subarachnoid (intrathecal) spaces around the spinal cord for pain management. It typically includes a procedural needle(s), syringe, catheter(s), and filter(s), but does not include medication. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FMF Syringe, piston
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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

68ebf2c2-0e39-4e47-a856-f4daa0c03810
June 12, 2018
3
November 14, 2016
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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
No Package DIs found
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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: 04046964941146 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)227-2862
BBMUS_Service.EmailOrders@bbraun.com
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