DEVICE: Perifix® (04046964178283)

Device Identifier (DI) Information

Perifix®
332217
In Commercial Distribution
332217
B. BRAUN MEDICAL INC.
04046964178283
GS1

10
002397347 *Terms of Use
PERIFIX® 18 Ga. x 3&fr ac12; in. (90 mm) Tuohy, PERIFIX 20 Ga. Closed Tip Catheter, 10 mL Glass Luer Lock LOR Tray (Kit)
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Epidural anaesthesia kit, medicated A collection of sterile devices, including a pharmaceutical(s), intended to be used to deliver an analgesic or anaesthetic agent to the epidural space for pain management. It typically consists of a procedural needle, a syringe, an analgesic/anaesthetic agent, and typically includes dressings, drapes, towels, or swabs. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
OGE Epidural anesthesia kit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Gauge (Catheter) : 20
Device Size Text, specify: Gauge epidural needle : 18
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Device Record Status

289894a3-e161-4145-a14b-02f71b7839c6
March 29, 2018
2
September 23, 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: 04046964178276 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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