DEVICE: Portex (00351688000036)

Device Identifier (DI) Information

Portex
A1244-27
In Commercial Distribution

SMITHS MEDICAL ASD, INC.
00351688000036
GS1

1
137835299 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
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 anaesthesia kit, non-medicated A collection of sterile devices 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, syringe, catheter, and a filter, but does not include medication. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
CAZ Anesthesia conduction kit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K965017 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

131897ee-a446-4ad8-84c3-ed3ee65ca4d9
July 06, 2018
3
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
30351688000037 10 00351688000036 In Commercial Distribution CASE
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Secondary DI

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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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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