| Primary Device ID | 00856525007396 |
| NIH Device Record Key | 73293072-178a-4d91-acd6-fbac15660e0c |
| Commercial Distribution Discontinuation | 2025-01-01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PFAB Large |
| Version Model Number | PFAB-L |
| Catalog Number | PFAB-L |
| Company DUNS | 609397224 |
| Company Name | SUN SCIENTIFIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856525007396 [Primary] |
| MHW | Dressing, Compression |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-10 |
| Device Publish Date | 2021-04-30 |
| 00850051939565 - AeroWrap™ Full Leg | 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k |
| 00850051939572 - AeroWrap™ Full Leg | 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k |
| 00850051939589 - AeroWrap™ Full Leg | 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k |
| 00850051939596 - AeroWrap™ Full Leg | 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k |
| 00850051939602 - AeroWrap™ Full Leg | 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k |
| 00850051939619 - AeroWrap™ Full Leg | 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k |
| 00850051939626 - AeroWrap™ Full Leg | 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k |
| 00850051939640 - AeroWrap™ Full Leg | 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k |