AccessGUDID - DEVICE: Portex (00351688060092)

GUDID

Device Identifier (DI) Information

Brand Name: Portex
Version or Model: 4911-22
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SMITHS MEDICAL ASD, INC.

Primary DI Number: 00351688060092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137835299 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

FDA Product Code

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Product Code	Product Code Name
CAZ	Anesthesia conduction kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K965017	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 16973486-d6f3-468a-b0b0-5c8a64290781
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 09, 2017