FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 00885380004394
·
Model: CAH35
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 00885380004394
- Version / Model
- CAH35
- Catalog Number
- CAH35
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-11
- Public Version
- 1
- Public Version Date
- 2019-07-19
- Public Version Status
- New
- Public Device Record Key
- c2aabc7c-d32d-4440-8b58-916e7038708d
Device Description
SELF ADHERENT BANDAGE 3IN X 5YD NONSTERILE LATEX 1CA/6BX/12EA SOFT BREATHABLE LIGHTWEIGHT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQM | BANDAGE, ELASTIC | General Hospital | 880.5075 | 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 | 50885380004399 | GS1 | CASE | 6 | In Commercial Distribution | |
| Package | 20885380004398 | GS1 | BOX | 24 | In Commercial Distribution | |
| Primary | 00885380004394 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 35 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius