FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 10885632107818
·
Model: BND3040
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 10885632107818
- Version / Model
- BND3040
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-15
- Public Version
- 2
- Public Version Date
- 2021-09-20
- Public Version Status
- Update
- Public Device Record Key
- 1914dc96-3ef4-4517-9c7a-e9eb410f8c08
Device Description
Bandage Compression With Trak 3-Layer System Contains Natural Rubber Latex MediChoice
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MHW | DRESSING, COMPRESSION | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13369 | Skin treatment/dressing-supportive limb/finger bandage, single-use | An elastic, tubular device intended to be worn over/around the limb (arm/leg) and/or finger of a patient affected by a skin condition/disorder (e.g., eczema, wound, fragile skin) to protect the skin typically after treatment with a medication (e.g., ointment, cream), and/or to support a dressing over a wound/injury; it is not designed for tissue support/compression. It is typically made of non-allergenic natural materials or a composite (e.g., viscose/nylon/elastane), and intended for use in the home and healthcare facility. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885632107816 | GS1 | 8 | In Commercial Distribution | ||
| Primary | 10885632107818 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from water damage. Protect from sunlight.