AccessGUDID - DEVICE: Three vaporizer mount (06944904086828)

GUDID

Device Identifier (DI) Information

Brand Name: Three vaporizer mount
Version or Model: 115-020218-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Primary DI Number: 06944904086828
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 654671304 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
47770	Anaesthesia unit, wall-mounted	An assembly of devices mounted on a framework and wall-mounted (static and typically hung on a medical device service rail system) designed to continuously or intermittently administer and monitor a mixture of gases [oxygen (O2), nitrous oxide (N2O), medical air, and anaesthetic agents] to provide a patient with an appropriate level of anaesthesia for a surgical procedure. It typically includes mechanical gas-delivery devices (e.g., flowmeters and vaporizers) and connects directly into the gas terminal units; it typically incorporates a patient breathing circuit and basic gas monitoring devices. The device is most often used in induction rooms and facilities for minor/short-stay surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSZ	Gas-machine, anesthesia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151954	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: acd5c72c-e230-442a-8093-cfc2b5d1e8a2
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016