FDA UDI
In Commercial Distribution
🇺🇸 United States
Elbow Pillow Pad (Ripstop/Microsuede)
DI: 00810006681642
·
Model: EPP01
·
PRIMO INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Elbow Pillow Pad (Ripstop/Microsuede)
- Primary DI
- 00810006681642
- Version / Model
- EPP01
- Catalog Number
- EPP01
- Company Name
- PRIMO INC
- Labeler DUNS
- 958758146
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-27
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- e0d0f2d5-8dd6-4eeb-b7b6-63f78c4625ab
Device Description
Elbow Pillow Pad (Ripstop/Microsuede)
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 |
|---|---|---|---|---|
| FMP | Protector, Skin Pressure | General Hospital | 880.6450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44284 | Arm friction/impact protector | A device designed to be worn over some length of the arm (various ranges from the base of the fingers to above the elbow) to provide a cover and/or cushion to protect the limb and its skin from friction and knocks against objects. It is typically made of fabric or soft padded materials and is held in place with bands or straps around the arm, or has a tubular sleeve design; it is not dedicated to the elbow. It is typically used by persons who have thinning skin or skin sores on their elbows/arms, 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 |
|---|---|---|---|---|---|---|
| Package | 00810006683042 | GS1 | CASE | 12 | In Commercial Distribution | |
| Primary | 00810006681642 | GS1 |