Duns Number:557223252
Device Description: GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test 30DAY
Catalog Number
00027430004
Brand Name
GEM 4000 PAK BG COOX 300 TEST 30 DAY
Version/Model Number
00027430004
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
K112995
Product Code
CHL
Product Code Name
ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
Public Device Record Key
f4883aa2-63a5-4fe2-b4ef-76d697856417
Public Version Date
September 14, 2021
Public Version Number
7
DI Record Publish Date
September 23, 2016
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 |