FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 20885380150033
·
Model: CHB5063
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 20885380150033
- Version / Model
- CHB5063
- Catalog Number
- CHB5063
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2019-06-04
- Public Version
- 3
- Public Version Date
- 2023-08-11
- Public Version Status
- Update
- Public Device Record Key
- 9afd23d3-ac05-4bc4-a81d-f408bfb0310f
Device Description
TOURNIQUET 0.75X12IN LATEX FREE BLUE TEXTURED PEDIATRIC
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAX | TOURNIQUET, NONPNEUMATIC | General, Plastic Surgery | 878.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35925 | Tourniquet cuff, single-use | A band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380150034 | GS1 | CASE | 4 | In Commercial Distribution | |
| Primary | 20885380150033 | GS1 | ||||
| Unit of Use | 10885380150036 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 65 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius