FDA UDI
In Commercial Distribution
🇺🇸 United States
Action®
DI: 00089904006486
·
Model: Repair Patch
·
ACTION PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Action®
- Primary DI
- 00089904006486
- Version / Model
- Repair Patch
- Catalog Number
- KIT002
- Company Name
- ACTION PRODUCTS, INC.
- Labeler DUNS
- 067543058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-21
- Public Version
- 1
- Public Version Date
- 2021-01-29
- Public Version Status
- New
- Public Device Record Key
- ed6ae837-29d9-4297-95a2-1d1dd0bf1a0f
Device Description
4"x4" Repair Kit
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KME | Bedding, Disposable, Medical | General Hospital | 880.6060 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60918 | Mattress repair patch | A non-sterile device intended to repair a mattress or other suitable soft surface (e.g., bedrail pad) where there is a tear, cut, or puncture, to prevent further damage and help promote hygiene. It is a small non-latex patch with an adhesive on one side intended to cover and adhere to the damaged surface and produce a smooth wipe-clean surface. It is typically available in a variety of shapes/sizes. Once applied this device cannot be reused on another surface. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00089904006486 | GS1 |
Customer Contacts
- Phone
- 301.797.1414
- [email protected]