FDA UDI
In Commercial Distribution
🇺🇸 United States
Avaline Medical NJ LLC
DI: 00810077212172
·
Model: HEP2
·
Avaline Medical NJ Limited Liability Company
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Avaline Medical NJ LLC
- Primary DI
- 00810077212172
- Version / Model
- HEP2
- Catalog Number
- HEP2
- Company Name
- Avaline Medical NJ Limited Liability Company
- Labeler DUNS
- 079767953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2021-10-15
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- df0a0de4-5fc4-4e72-939c-a6400a408b2c
Device Description
Knit Heel And Elbow Protector 2 PAIR
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| FMP | Protector, skin pressure | General Hospital | 880.6450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32858 | Elbow/ankle friction/impact protector | A device designed to be worn over the elbow and/or the ankle to provide a cushion to protect the joint(s) from friction against surfaces and knocks against objects. It is typically made from soft padded materials and held in place with straps; it is designed to cover only the joint(s) and is not intended to cover a larger portion of the arm or leg. It is typically used by persons that have tendencies for skin sores on their elbows, are bedridden, or prone to lack of control with their arms causing injury. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810077212158 | GS1 | ||||
| Primary | 00810077212172 | GS1 |
Customer Contacts
- Phone
- +1(732)813-7799 ext. 204
- [email protected]