AccessGUDID - DEVICE: Flex-Neck® (00884450330074)

GUDID

Device Identifier (DI) Information

Brand Name: Flex-Neck®
Version or Model: 00884450330074
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CF-4235/C
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 00884450330074
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184763290 *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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34916	Anaesthesia conduction catheter holder, sterile	A sterile device in the form of an adhesive backed pad with a locking mechanism that is used to secure an anaesthesia conduction catheter at the skin insertion site to prevent catheter migration. Also known as an epidural securement device. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FJS	Catheter, peritoneal, long-term indwelling

FDA Premarket Submission

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

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
Device Size Text, specify: Number of Cuffs-2 Cuffs
Device Size Text, specify: I.D. (mm)-2.5 mm
Device Size Text, specify: Catheter Tip configuration-Coiled
Device Size Text, specify: Overall Length Straight (cm)-42.0 cm

Device Record Status

Public Device Record Key: 18049ee3-ac48-4059-a6a2-c3b25a8c9714
Public Version Date: October 11, 2021
Public Version Number: 4
DI Record Publish Date: October 16, 2017