| Primary Device ID | 00810113683454 |
| NIH Device Record Key | 39d11bc6-7892-4e6f-addb-dd4eff5e72c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ManaCold Platinum Back Pad 2.0 |
| Version Model Number | MCOLDPAD02-BACK |
| Catalog Number | MCOLDPAD02-BACK |
| Company DUNS | 084042331 |
| Company Name | Manamed, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810113683454 [Primary] |
| ILO | Pack, Hot Or Cold, Water Circulating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-22 |
| Device Publish Date | 2025-09-12 |
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| 00810113682907 - ManaEZ Ankle 06 Small | 2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr |
| 00810113682914 - ManaEZ Ankle 06 Medium | 2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr |
| 00810113682921 - ManaEZ Ankle 06 Large | 2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr |
| 00810113682938 - ManaEZ Ankle 06 Extra Large | 2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr |
| 00810113682945 - ManaEZ Ankle 06 Extra Extra Large | 2025-10-06 The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes fr |
| 00810113683126 - ManaEZ Night Splint, Plantar Fasciitis, Small | 2025-10-06 Ideal for patients that need to stretch the Achilles Tendon or Plantar Fascia. Common indications are Plantar Fasciitis, Tight A |
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