FDA UDI
In Commercial Distribution
🇺🇸 United States
Redicare
DI: B70901040411
·
Model: Combine Trauma Dressing 5" x 9"
·
REDICARE LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
4
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Basic Information
- Brand Name
- Redicare
- Primary DI
- B70901040411
- Version / Model
- Combine Trauma Dressing 5" x 9"
- Catalog Number
- 0104041
- Company Name
- REDICARE LLC
- Labeler DUNS
- 800149346
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2020-07-28
- Public Version
- 1
- Public Version Date
- 2020-08-05
- Public Version Status
- New
- Public Device Record Key
- 53b9c9cb-7258-43b7-ba45-38dd44a4fa1a
Device Description
4 Sterile Combine Trauma Dressing Pads 5x9 inch 4/box
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59022 | Pressure bandage, non-latex, sterile | A sterile strip or roll of fabric or plastic material (non-latex) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema, provide support for varicose veins). It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B70901040412 | HIBCC | CARTON | 48 | In Commercial Distribution | |
| Primary | B70901040411 | HIBCC | ||||
| Unit of Use | B70901040410 | HIBCC |
Customer Contacts
- Phone
- 8665615650
- [email protected]