AccessGUDID - DEVICE: Western/Scott Fetzer (B929C4SU180FHTDBA0)

GUDID

Device Identifier (DI) Information

Brand Name: Western/Scott Fetzer
Version or Model: C4SU-180FHTDBA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C4SU-180FHTDBA
Company Name: Western Enterprises

Primary DI Number: B929C4SU180FHTDBA0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148634731 *Terms of Use

Device Description: PKGD: C4-SUC-180-FHT-DBA

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42834	Vacuum hose	A length of reinforced colour-coded flexible tubing intended to be connected to a vacuum-producing medical device, medical equipment, or a medical system to channel incoming suction. It has a thick wall to prevent collapse due to the negative pressure of the vacuum and typically produced according to ISO5359. It is available in various lengths, including standard coil lengths. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYX	Tubing, Pressure And Accessories

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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: 5d9d610b-7e0b-4072-a6e7-49f4f626a195
Public Version Date: August 14, 2024
Public Version Number: 3
DI Record Publish Date: May 27, 2022