FDA UDI
In Commercial Distribution
🇺🇸 United States
Protect U Guard Flexible Fabric Adhesive Bandages
DI: B086191421
·
Model: P19142
·
PROTECT U GUARD, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Protect U Guard Flexible Fabric Adhesive Bandages
- Primary DI
- B086191421
- Version / Model
- P19142
- Company Name
- PROTECT U GUARD, LLC
- Labeler DUNS
- 080070945
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- 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
- a1c18ae6-584e-42f1-bd68-735fd2461150
Device Description
Protect U Guard Flexible Fabric Adhesive Bandages Round 2.5cm
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 |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 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 |
|---|---|---|---|---|---|---|
| Package | B086291422 | HIBCC | CARTON | 15000 | In Commercial Distribution | |
| Primary | B086191421 | HIBCC | ||||
| Unit of Use | B086091420 | HIBCC |
Customer Contacts
- Phone
- 8138150530
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Circumference | 25 | Millimeter |