FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 20885380182928
·
Model: BCTH250
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 20885380182928
- Version / Model
- BCTH250
- Catalog Number
- BCTH250
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2021-12-18
- Public Version
- 1
- Public Version Date
- 2021-12-27
- Public Version Status
- New
- Public Device Record Key
- ecaeb5fb-ba18-486e-8479-f4044171d88f
Device Description
Blood Collection Tube Holder
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JKA | Tubes, vials, systems, serum separators, blood collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37566 | Blood collection tube holder, single-use | A hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380182929 | GS1 | CASE | 4 | In Commercial Distribution | |
| Primary | 20885380182928 | GS1 | ||||
| Unit of Use | 10885380182921 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- High: 60 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 45 Degrees Celsius