FDA UDI
In Commercial Distribution
🇺🇸 United States
SOL-CARE™ Safety Blood Collection Needle
DI: 00818392017298
·
Model: 110201030034
·
Sol-Millennium Medical, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- SOL-CARE™ Safety Blood Collection Needle
- Primary DI
- 00818392017298
- Version / Model
- 110201030034
- Company Name
- Sol-Millennium Medical, Inc.
- Labeler DUNS
- 069590113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-26
- Public Version
- 6
- Public Version Date
- 2025-04-29
- Public Version Status
- Update
- Public Device Record Key
- 272dc275-fda2-4152-bd65-cce91b154cf6
Device Description
SOL-CARE™ Safety Blood Collection Needle 25G*3/4*7inch (US)
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 |
|---|---|---|---|---|
| 17812 | Needle guard | A cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. This is a single-use device. | No | Active |
| 58497 | Blood collection set, invasive | A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20818392017292 | GS1 | Case | 4 | In Commercial Distribution | |
| Package | 10818392017295 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 00818392017298 | GS1 |
Customer Contacts
- Phone
- 833-637-0857
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Tubing Length:7 inches | ||
| Length | 20 | Millimeter | |
| Needle Gauge | 25 | Gauge |