DEVICE: Adhesive rings (05700693095240)

Device Identifier (DI) Information

Adhesive rings
0607230
In Commercial Distribution
0607230
Radiometer Basel AG
05700693095240
GS1

1600
481337657 *Terms of Use
Adhesive rings, 20mm (4x400)
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K003943 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 50 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

f5b448ea-bd2c-4042-ac95-7c4dc327e958
July 06, 2018
3
September 01, 2016
CLOSE

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
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: 55700693095245 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+459999999999
radiometer@radiometer.dk
CLOSE