AccessGUDID - DEVICE: Sontek Medical (10859758005006)

GUDID

Device Identifier (DI) Information

Brand Name: Sontek Medical
Version or Model: A1002 Inner Pack
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NextPhase Medical Devices LLC

Primary DI Number: 10859758005006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 072868941 *Terms of Use

Device Description: Suction Safe™ Swivel Y Inner pack

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):	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?
37704	Anaesthesia breathing circuit, single-use	An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZA	Connector, Airway (Extension)

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 052f5bbd-8d5a-4436-8f7c-19e5bc763a34
Public Version Date: February 28, 2025
Public Version Number: 1
DI Record Publish Date: February 20, 2025