Exacta™ 680128/A
GUDID 20884450321052
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Vascular catheter introduction set, nonimplantable| Primary Device ID | 20884450321052 |
| NIH Device Record Key | 01f3818e-e7f6-4b39-a822-7fbcd04fe851 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Exacta™ |
| Version Model Number | 10884450321055 |
| Catalog Number | 680128/A |
| Company DUNS | 595138793 |
| Company Name | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450321058 [Unit of Use] |
| GS1 | 10884450321055 [Primary] |
| GS1 | 20884450321052 [Package] Contains: 10884450321055 Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K941428
FDA Product Code
| DYB | INTRODUCER, CATHETER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-11 |
| Device Publish Date | 2019-06-03 |
On-Brand Devices [Exacta™]
| 20884450321045 | 10884450321048 |
| 20884450321052 | 10884450321055 |
| 20884450389991 | 10884450389994 |
| 20884450321069 | 10884450321062 |
| 20884450321038 | 10884450321031 |
Trademark Results [Exacta]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXACTA 90578735 not registered Live/Pending |
Exacta Systems, LLC 2021-03-15 |
 EXACTA 90578726 not registered Live/Pending |
Exacta Systems, LLC 2021-03-15 |
 EXACTA 88458205 5897318 Live/Registered |
Medtronic, Inc. 2019-06-04 |
 EXACTA 87701650 not registered Dead/Abandoned |
Sacks Holdings, Inc. 2017-11-29 |
 EXACTA 87096372 5169943 Live/Registered |
Haddad, Esther 2016-07-07 |
 EXACTA 86772276 4960074 Live/Registered |
Schwartz, Carl I. 2015-09-29 |
 EXACTA 86533748 5576135 Live/Registered |
Kimberly Jones 2015-02-12 |
 EXACTA 81008357 1008357 Dead/Cancelled |
U.S. Suzuki Motor Corporation 0000-00-00 |
 EXACTA 78714326 3135721 Dead/Cancelled |
Experiencia, Inc. 2005-09-16 |
 EXACTA 78239770 not registered Dead/Abandoned |
SpectraVerse, Inc. 2003-04-19 |
 EXACTA 77140103 3539340 Live/Registered |
Fiocchi of America, Inc. 2007-03-26 |
 EXACTA 76641511 3184307 Live/Registered |
Anderson, Joseph M. 2005-06-13 |
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