DEVICE: Portex (15019517076486)

Device Identifier (DI) Information

Portex
24-1355-64
In Commercial Distribution

ICU MEDICAL, INC.
15019517076486
GS1

1
118380146 *Terms of Use
No description.
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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?
58293 Epidural needle, non-threaded
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BSP NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K172823 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

548da67d-9b1a-4314-8349-b9755246f7b4
April 23, 2025
2
March 09, 2020
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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
35019517076480 20 15019517076486 In Commercial Distribution Case
55019517076484 10 35019517076480 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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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