AccessGUDID - DEVICE: Application set (05700693095219)

GUDID

Device Identifier (DI) Information

Brand Name: Application set
Version or Model: 0607110
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0607110
Company Name: Radiometer Basel AG

Primary DI Number: 05700693095219
Issuing Agency: GS1
Commercial Distribution End Date: June 25, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 481337657 *Terms of Use

Device Description: Application set

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?
37178	Transcutaneous blood gas monitor sensor	A device intended to be used with a transcutaneous blood gas monitor to measure a patient's blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), and/or blood oxygen saturation transcutaneously (through the skin). Gases diffuse through the skin and into this sensor at the skin surface, where it transmits electrical signals to the parent device for analysis. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLK	Monitor, oxygen, cutaneous, for infant not under gas anesthesia
LKD	MONITOR, CARBON-DIOXIDE, CUTANEOUS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 26f0a520-5291-4d08-b74c-deb023886b97
Public Version Date: June 22, 2022
Public Version Number: 4
DI Record Publish Date: September 01, 2016