GEM Premier ChemSTAT 00044000000
GUDID 08426951293865
GEM Premier ChemSTAT Analyzer
INSTRUMENTATION LABORATORY COMPANY
Blood gas/haemoximetry analyser IVD, laboratory, automated| Primary Device ID | 08426951293865 |
| NIH Device Record Key | 57e08ca9-d88f-4e67-aaa1-7c3ccfb81bcd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEM Premier ChemSTAT |
| Version Model Number | 00044000000 |
| Catalog Number | 00044000000 |
| Company DUNS | 557223252 |
| Company Name | INSTRUMENTATION LABORATORY COMPANY |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08426951293865 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183546
FDA Product Code
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph |
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 | 2019-07-17 |
| Device Publish Date | 2019-06-28 |
Devices Manufactured by INSTRUMENTATION LABORATORY COMPANY
| 08430793242998 - HEMOSIL RIVAROXABAN CONTROLS | 2024-07-30 1. Rivaroxaban Low Control (Cat. No. 0020015510): 5 x 1mL vials 2. Rivaroxaban High Control (Cat. No. 0020015520): 5 x 1mL vial |
| 08430793243001 - HEMOSIL RIVAROXABAN CALIBRATORS | 2024-07-30 1. Rivaroxaban Calibrator 1 (Cat. No. 0020015410): 5 x 1mL vials 2. Rivaroxaban Calibrator 2 (Cat. No. 0020015420) : 5 x 1mL vi |
| 00195226001129 - HemosIL Chromogenic Factor IX | 2024-07-17 HemosIL Chromogenic Factor IX |
| 00195226000528 - ACL TOP 770 | 2024-05-23 ACL TOP 770 |
| 00195226000535 - ACL TOP 770 LAS | 2024-05-23 ACL TOP 770 LAS |
| 00195226000542 - ACL TOP 770s | 2024-05-23 ACL TOP 770s |
| 00195226000559 - ACL TOP 570 | 2024-05-23 ACL TOP 570 |
| 00195226000566 - ACL TOP 370 | 2024-05-23 ACL TOP 370 |
Trademark Results [GEM Premier ChemSTAT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GEM PREMIER CHEMSTAT 86815492 not registered Live/Pending |
Instrumentation Laboratory Company 2015-11-10 |
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