i-STAT 03P92-25
GUDID 10054749000200
CK-MB Cartridge
ABBOTT POINT OF CARE INC.
Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent| Primary Device ID | 10054749000200 |
| NIH Device Record Key | 093f0304-998e-4b59-b2a6-124ad308eba6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | i-STAT |
| Version Model Number | 03P92-25 |
| Catalog Number | 03P92-25 |
| Company DUNS | 079226216 |
| Company Name | ABBOTT POINT OF CARE INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com | |
| Phone | +1(800)366-8020 |
| techsvc@apoc.abbott.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00054749000203 [Package] Package: Case [25 Units] In Commercial Distribution |
| GS1 | 10054749000200 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051433
FDA Product Code
| MYT | BIOSENSOR, IMMUNOASSAY, CPK OR ISOENZYMES |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-09-11 |
| Device Publish Date | 2016-09-09 |
On-Brand Devices [i-STAT]
| 00054749003914 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003907 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003891 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003884 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003877 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003860 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003853 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003846 | i-Stat 1 Wireless Analyzer |
| 00054749003839 | i-Stat 1 Wireless Analyzer |
| 00054749003822 | i-Stat 1 Wireless Analyzer |
| 00054749003815 | i-Stat 1 Wireless Analyzer |
| 00054749003808 | i-Stat 1 Wireless Analyzer |
| 00054749003792 | i-Stat 1 Wireless Analyzer |
| 00054749003785 | i-Stat 1 Wireless Analyzer |
| 00054749003778 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003761 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003754 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003747 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003730 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003723 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003716 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003709 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003693 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003600 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749003587 | i-Stat 1 Wireless Analyzer |
| 00054749003402 | i-Stat 1 Wireless Analyzer |
| 00054749003396 | i-Stat 1 Wireless Analyzer |
| 00054749003389 | i-Stat 1 Wireless Analyzer |
| 00054749003372 | i-Stat 1 Wireless Analyzer |
| 00054749003365 | i-Stat 1 Wireless Analyzer |
| 00054749003358 | i-Stat 1 Wireless Analyzer |
| 00054749003044 | i-Stat 1 Wireless Analyzer |
| 00054749002528 | i-Stat 1 Wireless Analyzer |
| 00054749001408 | i-Stat 1 Wireless Analyzer |
| 00054749001262 | MILITARY KIT |
| 00054749001248 | i-STAT ACT, CONTROL LEVEL 2 |
| 00054749001231 | i-STAT ACT, CONTROL LEVEL 1 |
| 00054749001224 | i-STAT PT, CONTROL LEVEL 2 |
| 00054749001217 | i-STAT PT, CONTROL LEVEL 1 |
| 00054749000340 | i-STAT 1 Analyzer, Immuno Ready |
| 00054749005093 | i-STAT 1 Wireless |
| 00054749005512 | Cartridge, Chem8+ |
| 00054749005529 | i-STAT 1 Wireless |
| 00054749005222 | i-Stat 1 Wireless Analyzer |
| 00054749005215 | i-Stat 1 Wireless Analyzer |
| 00054749005208 | i-Stat 1 Wireless Analyzer |
| 00054749005192 | i-Stat 1 Wireless Analyzer |
| 00054749005185 | i-Stat 1 Wireless Analyzer |
| 00054749005178 | i-Stat 1 Wireless Analyzer |
| 00054749005161 | i-Stat 1 Wireless Analyzer |
Trademark Results [i-STAT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 I-STAT 77298232 3577397 Dead/Cancelled |
ICS BUILDING TECHNOLOGIES 2007-10-08 |
 I-STAT 75171521 2177858 Live/Registered |
ABBOTT POINT OF CARE INC. 1996-09-18 |
 I-STAT 75171518 2196980 Live/Registered |
ABBOTT POINT OF CARE INC. 1996-09-18 |
 I-STAT 74665634 2085232 Live/Registered |
ABBOTT POINT OF CARE INC. 1995-04-25 |
 I-STAT 74057416 1879156 Live/Registered |
I-STAT CORPORATION 1990-05-07 |
 I-STAT 73789592 not registered Dead/Abandoned |
INTERNATIONAL CARDIOVASCULAR MEDICINE, INC. 1989-03-27 |
 I-STAT 73728329 1538585 Dead/Cancelled |
I-STAT CORPORATION 1988-05-04 |
 I-STAT 73007703 1002688 Live/Registered |
CONCEPT, INC. 1973-11-30 |
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