FDA UDI
In Commercial Distribution
🇺🇸 United States
SOL-M™ Multi-Sample Needle
DI: 00818392015409
·
Model: 110201020004
·
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™ Multi-Sample Needle
- Primary DI
- 00818392015409
- Version / Model
- 110201020004
- 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
- 923b358b-453f-4bd2-bacf-0ac4f48e9edf
Device Description
SOL-M™ Multi-Sample Needle 21G*1”
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 |
|---|---|---|---|---|
| 35209 | Non-fixed blood collection needle | A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10818392015406 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00818392015409 | GS1 | ||||
| Package | 20818392015403 | GS1 | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 833-637-0857
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 25 | Millimeter | |
| Needle Gauge | 21 | Gauge |