FDA UDI
In Commercial Distribution
🇺🇸 United States
Protect U Guard Non-Woven Dressing
DI: B086191231
·
Model: P19123
·
PROTECT U GUARD, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Protect U Guard Non-Woven Dressing
- Primary DI
- B086191231
- Version / Model
- P19123
- Company Name
- PROTECT U GUARD, LLC
- Labeler DUNS
- 080070945
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2020-08-21
- Public Version
- 1
- Public Version Date
- 2020-08-31
- Public Version Status
- New
- Public Device Record Key
- f189e1ed-f7b1-4225-9ed6-d4e8ce750b1a
Device Description
Protect U Guard Non-Woven Dressing 10x35cm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34864 | Adhesive bandage | A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | B086091230 | HIBCC | ||||
| Primary | B086191231 | HIBCC | ||||
| Package | B086291232 | HIBCC | CARTON | 500 | In Commercial Distribution |
Customer Contacts
- Phone
- 8138150530
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 10 | Centimeter | |
| Length | 35 | Centimeter |