| Primary Device ID | 00810113681092 |
| NIH Device Record Key | 088e4c9b-fee3-490a-9b5a-066b60797479 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ManaMed Inc |
| Version Model Number | PlasmaWave Calf Sleeve |
| Catalog Number | M-42 |
| Company DUNS | 084042331 |
| Company Name | MANAMED 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com | |
| Phone | 888-508-0712 |
| support@manamed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810113681092 [Primary] |
| JOW | Sleeve, Limb, Compressible |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-06-03 |
| Device Publish Date | 2022-12-30 |
| 00810113682488 | The PrevenTech is intended to be an easy to use sequential compression system, prescribed by a p |
| 00810113682549 | ManaEZ Ice Wrap Back is a quick fitting, universal, back orthosis. This back brace also includes |
| 00810113682532 | ManaEZ Ice Wrap Shoulder is a quick fitting, universal, shoulder orthosis. This shoulder brace a |
| 00810113682525 | A back and thigh extension strap for devices within our ManaEZ Hip line |
| 00810113682617 | This device is universal, this product does not exist. Cannot delete record |
| 00810113682600 | ManaEZ Ice Wrist is a quick fitting, universal, wrist orthosis. This wrist brace also includes a |
| 00810113682624 | The PlasmaFlow is intended to be an easy to use sequential compression system, prescribed by a p |
| 00810113682648 | Replacement abduction pillow used to keep shoulder aligned with sling. |
| 00810113682631 | Replacement abduction pillow with pockets for phone and water bottles used to keep shoulder alig |
| 00810113682679 | ManaCold Platinum Hip Pad attachment is used to decrease pain, swelling, and muscle spasms after |
| 00810113682662 | ManaCold Platinum Back Pad attachment is used to decrease pain, swelling, and muscle spasms afte |
| 00810113682655 | ManaCold Platinum Ankle Pad attachment is used to decrease pain, swelling, and muscle spasms aft |
| 00810113681092 | Reusable extra large size compression calf garment, increases venous blood flow to help prevent |