FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Protection Products Inc.
DI: 10809160219003
·
Model: ERT0005
·
MEDICAL ACTION INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Protection Products Inc.
- Primary DI
- 10809160219003
- Version / Model
- ERT0005
- Company Name
- MEDICAL ACTION INDUSTRIES INC.
- Labeler DUNS
- 092364462
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-19
- Public Version
- 2
- Public Version Date
- 2019-07-11
- Public Version Status
- Update
- Public Device Record Key
- f088a880-b5dd-4f01-9f14-e7b766884952
- Distribution End Date
- 2019-07-10
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| MAC | Decontamination kit | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17983 | Infectious waste spill kit | A set of devices used to clean up spillage of infectious material. It provides equipment and material for an appropriate method for removing the spillage, and includes the proper container for the disposal of the spillage. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20809160219000 | GS1 | 16 | Not in Commercial Distribution | 2019-07-10 | |
| Primary | 10809160219003 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE AT ROOM TEMPERATURE
- Type
- Special Storage Condition, Specify