| Primary Device ID | 00860005762668 |
| NIH Device Record Key | 8735f80d-3aad-4ac2-927c-40d0ed7ce231 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acanthus |
| Version Model Number | ANGTH019801 |
| Catalog Number | ANGTH019801 |
| 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 | 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860005762668 [Primary] |
| GS1 | 10860005762665 [Package] Package: Case [30 Units] In Commercial Distribution |
| GS1 | 20860005762662 [Package] Package: Case [60 Units] In Commercial Distribution |
| GS1 | 30860005762669 [Package] Package: Case [100 Units] In Commercial Distribution |
| GS1 | 40860005762666 [Package] Package: Case [30 Units] In Commercial Distribution |
| GS1 | 50860005762663 [Package] Package: Case [60 Units] In Commercial Distribution |
| GS1 | 60860005762660 [Package] Package: Case [100 Units] In Commercial Distribution |
| KGX | Tape And Bandage, Adhesive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-14 |
| Device Publish Date | 2023-08-04 |
| 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 |