Duns Number:557223252
Device Description: GEM 5000 BG COOX TBILI 150 Test PAK 31 DAY (pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, Met GEM 5000 BG COOX TBILI 150 Test PAK 31 DAY (pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, tBili Cartridge)
Catalog Number
00055415005XC
Brand Name
GEM Premier 5000 PAK BG COOX TBILI (150 TEST)
Version/Model Number
00055415005XC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160412
Product Code
CHL
Product Code Name
ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
Public Device Record Key
5af866b6-40df-47f4-8f05-bce87deca0f8
Public Version Date
July 14, 2021
Public Version Number
6
DI Record Publish Date
March 29, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 272 |