FDA UDI
In Commercial Distribution
🇺🇸 United States
SOL-M™ Holder with Male Luer Lock Adapter
DI: 00818392018158
·
Model: 110201050003
·
Sol-Millennium Medical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- SOL-M™ Holder with Male Luer Lock Adapter
- Primary DI
- 00818392018158
- Version / Model
- 110201050003
- Company Name
- Sol-Millennium Medical, Inc.
- Labeler DUNS
- 069590113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-03
- Public Version
- 6
- Public Version Date
- 2025-04-29
- Public Version Status
- Update
- Public Device Record Key
- 59e120a7-3b0d-4a4d-acac-82226d15bf80
Device Description
SOL-M™ Tube Holder with Luer Lock Adapter
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
- Yes
- 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 |
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 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 | 20818392018152 | GS1 | Case | 4 | In Commercial Distribution | |
| Package | 10818392018155 | GS1 | Box | 200 | In Commercial Distribution | |
| Primary | 00818392018158 | GS1 |
Customer Contacts
- Phone
- 833-637-0857
- [email protected]