AccessGUDID - DEVICE: "Sunset Healthcare Durable CPAP Tubing 18"" 19mm I.D. with 22mm Cuffs Gray" (00848530070007)

GUDID

Device Identifier (DI) Information

Brand Name: "Sunset Healthcare Durable CPAP Tubing 18"" 19mm I.D. with 22mm Cuffs Gray"
Version or Model: TUB0018
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TUB0018
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530070007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: "Sunset Healthcare Durable CPAP Tubing 18"" 19mm I.D. with 22mm Cuffs Gray"

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?
61833	Inspiratory/expiratory limb respiratory tubing, reusable	A length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a reusable device intended to be cleaned/disinfected prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZO	Set, Tubing And Support, Ventilator (W Harness)

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: 111c8452-2d04-44a2-aaae-c4c031b4aee2
Public Version Date: October 22, 2018
Public Version Number: 1
DI Record Publish Date: September 19, 2018