AccessGUDID - DEVICE: MCR (06946430400963)

GUDID

Device Identifier (DI) Information

Brand Name: MCR
Version or Model: MCRTM-I
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Primary DI Number: 06946430400963
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 543482946 *Terms of Use

Device Description: Anesthesia Mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air and/or oxygen. The mask is a Non-Sterile Product for single patient use.

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):	Yes
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?
46232	Anaesthesia face mask, single-use	A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSJ	Mask, Gas, Anesthetic

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: 5754a705-4cac-4b0c-8c08-d16b7926db9a
Public Version Date: January 31, 2019
Public Version Number: 1
DI Record Publish Date: December 31, 2018