AccessGUDID - DEVICE: ClearMate (10807141000107)

GUDID

Device Identifier (DI) Information

Brand Name: ClearMate
Version or Model: 128222
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Thornhill Research Inc

Primary DI Number: 10807141000107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 205151975 *Terms of Use

Device Description: Assy, ClearMate, DISS, US

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):	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?
62595	Oxygen/air breathing gas mixer, emergency	A portable mechanical device designed to mix air and oxygen (O2) for mobile O2 administration during first aid or emergency situations. It is a hand-held compact unit designed to be connected to an O2 gas container and includes an O2/air mixing valve, a filter for the removal of exhaled carbon dioxide (CO2), a bag for exhaled gas collection and recycling (rebreathing functionality), and connectors (e.g., for attachment to a breathing mask). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QFB	Isocapnic Ventilation Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN170044	000

Device Exempt from Premarket Submission: No 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: b76f2017-a3e4-492d-aaca-0e80ab620b1c
Public Version Date: April 28, 2023
Public Version Number: 2
DI Record Publish Date: October 01, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-888-597-1325
Email: info@thornhillmedical.com

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