FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ABS Velcro Pad
DI: 00869284000225
·
Model: Model 4001
·
NIMBIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ABS Velcro Pad
- Primary DI
- 00869284000225
- Version / Model
- Model 4001
- Catalog Number
- ABS-4001
- Company Name
- NIMBIC SYSTEMS, INC.
- Labeler DUNS
- 868730834
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-20
- Public Version
- 4
- Public Version Date
- 2022-02-24
- Public Version Status
- Update
- Public Device Record Key
- 339a9c54-efd0-4ba8-a199-733d7de09ce7
- Distribution End Date
- 2020-11-24
Device Description
Box of 10 Velcro Pads
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ORC | Air Filter Portable Apparatus | General, Plastic Surgery | 878.5070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18113 | High-efficiency filter air cleaner, mobile | A mains electricity (AC-powered) device that uses a combination of a prefilter and a high-efficiency particulate air (HEPA) filter to remove 99.97% of particles greater than 0.3 microns. This device is frequently used to prevent the transmission of tuberculosis (TB) and other diseases caused by airborne pathogens. It is designed to be moved from one location to another. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00869284000225 | GS1 |
Customer Contacts
- Phone
- 281-565-5750
- [email protected]