AccessGUDID - DEVICE: CPAP Tube 6 ft (00848530103859)

GUDID

Device Identifier (DI) Information

Brand Name: CPAP Tube 6 ft
Version or Model: TUB006LA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530103859
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 6 Foot 19mm I.D. with 22mm Cuffs Gray - For Sale in Latin America

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
GAZ	Tubing, Noninvasive

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: 5f582ab7-f018-4c3d-9850-6251a41c8324
Public Version Date: May 31, 2024
Public Version Number: 1
DI Record Publish Date: May 23, 2024