FDA UDI
In Commercial Distribution
🇺🇸 United States
B-COOL KNEE IMMOB 20" W/POCKETS
DI: 00840314812339
·
Model: HM2642
·
Hausmann Enterprises, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- B-COOL KNEE IMMOB 20" W/POCKETS
- Primary DI
- 00840314812339
- Version / Model
- HM2642
- Company Name
- Hausmann Enterprises, LLC
- Labeler DUNS
- 001892660
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-31
- Public Version
- 1
- Public Version Date
- 2025-02-10
- Public Version Status
- New
- Public Device Record Key
- 0de8814a-5939-43a0-a064-fbc0afe6f8da
Device Description
B-COOL KNEE IMMOB 20" W/POCKETS SKU HM2642
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITQ | Joint, Knee, External Brace | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56282 | Knee support/thermal therapy bandage | A non-sterile fabric material formed to fit around the knee and intended to provide pressure to support the joint following injury (e.g., sports injuries), disease (e.g., rheumatism), and/or surgery; it is designed to accommodate the insertion of a hot/cold pack(s) to provide heat or cold therapy for the skin and underlying tissues to facilitate the reduction of oedema and pain. The device typically includes fasteners; it may be used in a healthcare facility or at home. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840314812339 | GS1 |