ManaMed
- Primary DI
- 00810113680590
- Brand
- ManaMed
- Company
- Manamed, Inc.
- Model
- ManaEZ Ice Wrap Knee
- Catalog number
- EZIWKN01
- Device description
- ManaEZ Ice Wrap Knee is a quick fitting, universal, knee range of motion orthosis. This knee brace also includes an ice pack.Removable ice packLightweight, latex free breathable materialEffortless application, universal size with hook and loop closureDesigned for either left or right leg
- Published
- 2022-06-15
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- OTC
- true
Product Codes#
| Code | Name |
|---|---|
| ITQ | Joint, Knee, External Brace |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| ITQ | Joint, Knee, External Brace | Physical Medicine | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00810113680590 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00810113680590 | 00810113680590 | 810113680590 | 0810113680590 |
GMDN Terms#
| Term | Definition |
|---|---|
| Moist-cold pack | A non-sterile device intended to be temporarily applied to a particular area of the body surface to provide moist cold. It typically consists of a disposable pad/pack/towel that includes an overlapping of several layers of fabric (e.g., gauze, cotton) and is intended to apply moist cold to the tissues after immersion in cold water and freed from excess moisture; it is not a compression bandage. It is typically used for temporary vasoconstriction of superficial blood vessels to help control bleeding, to inhibit inflammation and microbial activity in the early stages of infection, and to prevent/control oedema after strains or contusions. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 084042331
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00810113688473 | ManaMed Inc | ManaMed Ultrasound Coupling Gel | MANAGEL01 | 2022-12-31 |
| 00810113684154 | ManaEZ Wrist Left, Extra Large | EZW3908L-XL | EZW3908L-XL | 2025-10-17 |
| 00810113684161 | ManaEZ Wrist Left, Extra Small | EZW3908L-XS | EZW3908L-XS | 2025-10-17 |
| 00810113684178 | ManaEZ Wrist Right, Extra Large | EZW3908R-XL | EZW3908R-XL | 2025-10-17 |
| 00810113684185 | ManaEZ Wrist Right, Extra Small | EZW3908R-XS | EZW3908R-XS | 2025-10-17 |
| 00810113682969 | "ManaEZ Single Panel Knee Immobilizer 18""" | EZIMM01-18 | EZIMM01-18 | 2025-11-25 |
| 00810113682976 | "ManaEZ Single Panel Knee Immobilizer 20""" | EZIMM01-20 | EZIMM01-20 | 2025-11-25 |
| 00810113682983 | "ManaEZ Single Panel Knee Immobilizer 24""" | EZIMM01-24 | EZIMM01-24 | 2025-11-25 |
| 00810113682990 | "ManaEZ 3 Panel Knee Immobilizer 18""" | EZ3PIMM01-18 | EZ3PIMM01-18 | 2025-11-25 |
| 00810113683003 | "ManaEZ 3 Panel Knee Immobilizer 20""" | EZ3PIMM01-20 | EZ3PIMM01-20 | 2025-11-25 |
| 00810113683010 | "ManaEZ 3 Panel Knee Immobilizer 24""" | EZ3PIMM01-24 | EZ3PIMM01-24 | 2025-11-25 |
| 00810113683294 | "ManaEZ 3 Panel Knee Immobilizer 16""" | EZ3PIMM01-16 | EZ3PIMM01-16 | 2025-11-25 |
| 00810113682600 | ManaMed Inc | ManaEZ Ice Wrist | EZIWST01 | 2022-10-13 |
| 00850998008119 | ManaMed | ManaEZ Wrist Universal Right | EZW3908R | 2022-06-20 |
| 00850998008126 | ManaMed | ManaEZ Wrist Universal Left | EZW3908L | 2022-06-20 |
| 00810113683065 | ManaEZ ROM Ice Short | EZR001-XSM | EZR001-XSM | 2025-10-17 |
| 00810113683515 | ManaEZ Hip Ice CureTech | EZHIP01B-CT | EZHIP01B-CT | 2025-10-03 |
| 00810113683522 | ManaEZ ROM Ice CureTech | EZR001-CT | EZR001-CT | 2025-10-03 |
| 00810113683539 | ManaEZ Shoulder Ice CureTech | EZSHLD-CT | EZSHLD-CT | 2025-10-03 |
| 00810113683577 | ManaEZ Ice Long Duration Knee | EZLDIP-KN | EZLDIP-KN | 2025-11-25 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00049696508377 | THERA Plus | FOURSTAR GROUP INC. | ITQ | 2026-06-09 |
| 00057475210434 | BIOS Living | Thermor Ltd | ITQ | 2023-03-31 |
| 00609271200135 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200159 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200173 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200180 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200197 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200333 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200357 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200371 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200388 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200395 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271210509 | 20'' DLX 3-PANEL KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271210608 | 20'' DLX 3-PANEL KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271210806 | 20'' DLX 3-PANEL KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610774 | "Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610781 | "Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (medium)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610798 | "Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610804 | "Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (x-large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610811 | "Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (small)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610828 | "Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (medium)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610835 | "Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610842 | "Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (x-large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610859 | "Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (xx-large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610866 | "Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (small)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610873 | "Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (x-large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610880 | "Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (xx-large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610897 | "Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (small)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610903 | "Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (medium)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610910 | "Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |