AccessGUDID - DEVICE: Newport Medical (10884521540545)

GUDID

Device Identifier (DI) Information

Brand Name: Newport Medical
Version or Model: BCD23801P-EL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Newport Medical Instruments, Inc.

Primary DI Number: 10884521540545
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050334275 *Terms of Use

Device Description: 180"" Pediatric (15 mm ID) J Ventilation Breathing Circuit Without Water Trap

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):	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?
37705	Ventilator breathing circuit, reusable	An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAI	Circuit, breathing (w connector, adaptor, y piece)

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
Special Storage Condition, Specify: Store in Cool Dry Place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Inside Diameter, 15, mm;
Length: 180 Inch

Device Record Status

Public Device Record Key: ad9926b3-a26d-45e5-8a3f-6fed567018cf
Public Version Date: November 10, 2023
Public Version Number: 4
DI Record Publish Date: September 20, 2018