| Primary Device ID | 00860008614650 |
| NIH Device Record Key | 28c807d3-1377-4a24-bc83-fe0988988c34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AtlanticMED |
| Version Model Number | ATL-HCGEL-1015 |
| Company DUNS | 117485067 |
| Company Name | Atlantic Trading 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860008614650 [Primary] |
| GS1 | 10860008614657 [Package] Package: Case [24 Units] In Commercial Distribution |
| IME | Pack, Hot Or Cold, Reusable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-17 |
| Device Publish Date | 2022-11-09 |
| 00860008614667 | Perineal Instant Cold Pack. Highly absorbent. Adhesive tab. |
| 00860008614650 | RESUSABLE GEL PACK, 12 X 29 CM, 350 G, PE & NYLON |
| 00860008614643 | INSTANT COLD PACK, 15.3 X22.9 CM, 237 G, PE & NYLON |
| 00860008614636 | INSTANT COLD PACK, 12.7 X 15.3 CM, 109 G, PE & NYLON |
| 00860008614629 | INSTANT HOT PACK, 15.3 X22.9 CM, 237 G, PE & NYLON |
| 00860008614612 | INSTANT HOT PACK, 12.7 X 15.3 CM, 109 G, PE & NYLON |
| 00860008614605 | INFANT HEEL WARMER, 12 X 8.5 CM, 57 G, PE |
| 10860008614671 | Surgical N95 Respirator, NIOSH Approved, Berry-Compliant, Made-in-the-USA |