| Primary Device ID | 20886333220902 |
| NIH Device Record Key | 4f0ae573-1db5-49cd-bb95-a18d874a22c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Centesis Procedure Kit |
| Version Model Number | APIG1280K |
| Catalog Number | APIG1280K |
| Company DUNS | 140727624 |
| Company Name | ARGON MEDICAL DEVICES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886333220908 [Primary] |
| GS1 | 20886333220902 [Package] Contains: 00886333220908 Package: Box [10 Units] In Commercial Distribution |
| OJT | Aspiration Tray |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-22 |
| Device Publish Date | 2022-07-14 |
| 20886333220902 | Centesis Procedure Kit 8F x 16cm Skater™ Safety Centesis Catheter with Pigtail and Blunt Retra |
| 20886333220889 | Centesis Procedure Kit 6F x 16cm Skater™ Safety Centesis Catheter with Pigtail and Blunt Retra |
| 20886333221008 | Centesis Procedure Kit 5F x 10cm Skater™ Safety Centesis Catheter with Air Lock Valve |
| 20886333220995 | Centesis Procedure Kit 8F x 12cm Skater™ Safety Centesis Catheter with Air Lock Valve |
| 20886333220735 | Centesis Procedure Kit Drug Free with Safety Devices and Thoracentesis Catheter with 14ga Needle |