FDA UDI
In Commercial Distribution
🇺🇸 United States
SOL-CARE™ Blood Collection Tube Holder Set
DI: 10818392012641
·
Model: 7001BCD
·
SOL-MILLENNIUM MEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- SOL-CARE™ Blood Collection Tube Holder Set
- Primary DI
- 10818392012641
- Version / Model
- 7001BCD
- Company Name
- SOL-MILLENNIUM MEDICAL INC
- Labeler DUNS
- 069590113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 6
- Public Version Date
- 2020-11-23
- Public Version Status
- Update
- Public Device Record Key
- 32904e63-961f-4dca-a3bd-c6a9483ec1c3
Device Description
To enable withdrawal of blood samples from a patient. The device is designed to prevent accidental needle stick injuries. The needle is retracted via a retraction tube.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| FMI | Needle, hypodermic, single lumen | General Hospital | 880.5570 | 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 | 20818392012648 | GS1 | Case | 8 | In Commercial Distribution | |
| Primary | 10818392012641 | GS1 | ||||
| Unit of Use | 00818392012644 | GS1 |
Customer Contacts
- Phone
- +1(404)973-2200
- [email protected]