AccessGUDID - DEVICE: 1-Slot CO2/O2 Module w/ kit (Neo) (06936415902759)

GUDID

Device Identifier (DI) Information

Brand Name: 1-Slot CO2/O2 Module w/ kit (Neo)
Version or Model: 115-053712-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Primary DI Number: 06936415902759
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?
46822	Carbon dioxide sensor/cable	An assembly of electrical wires with a detector (typically infrared spectroscopic) at the distal end designed to connect a carbon dioxide (CO2) cuvette, or other form of translucent window placed in an anaesthetic or ventilatory breathing circuit, with a CO2 patient monitor, for the transmission of electrical signals to measure the CO2 concentration in gases expired by the patient. The proximal end of the device typically has a multi-pinned plug for insertion into the patient monitor. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCJ	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182075	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: 717fa681-42bc-4ee2-a490-6ebd435c71db
Public Version Date: May 18, 2020
Public Version Number: 1
DI Record Publish Date: May 10, 2020