| Primary Device ID | 00860005762613 |
| NIH Device Record Key | c7746008-3570-4320-a3c9-2f596787f57f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acanthus |
| Version Model Number | ACC019795 |
| Catalog Number | ACC019795 |
| Company DUNS | 065124205 |
| Company Name | Acanthus Medical Creations LLC |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Lumen/Inner Diameter | 21.98 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Special Storage Condition, Specify | Between 0 and 0 *Standard room temperature conditions |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860005762613 [Primary] |
| GS1 | 00860005762620 [Package] Package: Box [30 Units] In Commercial Distribution |
| GS1 | 00860005762644 [Package] Package: Box [20 Units] In Commercial Distribution |
| GS1 | 00860005762668 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 00860005762682 [Package] Package: Box [50 Units] In Commercial Distribution |
| NNY | Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-23 |
| Device Publish Date | 2021-03-15 |
| 00860005762606 | Acanthus Condom Catheter, Size M/L |
| 00860005762613 | Acanthus Condom Catheter Size S/M |
| 00860005762651 | Acanthus Nasal-bridge Protector |
| 00860005762620 | Acanthus Condom Catheter Small-Medium |
| 00860005762637 | Acanthus Nasal Cannula Holder |
| 00860005762668 | Acanthus Naso-gastric Tube Holder |
| 00860010190807 | Acanthus Nasal-bridge Protector for CPAP Mask Case of 5 |
| 00860010190821 | Acanthus Nasal-bridge Protector for CPAP Mask Case of 20 |
| 00860010190814 | Acanthus Nasal-bridge Protector for CPAP Mask Case of 10 |
| 00860010190838 | Acanthus Nasal Cannula Holder Case of 5 |
| 00860010190852 | Acanthus Nasal Cannula Holder Case of 20 |
| 00860010190845 | Acanthus Nasal Cannula Holder Case of 10 |
| 00860010190876 | Acanthus Nasal-bridge Protector for CPAP Mask Case of 7 |
| 00860010190890 | Acanthus Nasal-bridge Protector for CPAP Mask Case of 15 |
| 00860010482650 | Acanthus Nasal-bridge Protector Double for CPAP Mask Case of 12 |