AccessGUDID - DEVICE: Deluxe Tubing Wrap (00848530020057)

GUDID

Device Identifier (DI) Information

Brand Name: Deluxe Tubing Wrap
Version or Model: CAP2002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CAP2002
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530020057
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: 6ft Nylon CPAP Tubing Wrap

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:	No
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?
32202	Aerosol delivery tubing	A non-sterile length of a flexible, hollow tube, typically large bore (e.g., 22 mm), used in conjunction with an oxygen mask, endotracheal (ET) tube, humidifier, or nebulizer for the delivery of aerosolized humidification, typically oxygen enriched. It is typically supplied in standard coil lengths and is cut by clinical staff to usable lengths. This is a single-use 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: 8d73eb09-7033-4daa-9f7f-fde665491e9f
Public Version Date: August 29, 2018
Public Version Number: 1
DI Record Publish Date: July 29, 2018