FDA UDI
In Commercial Distribution
🇺🇸 United States
SOL-M 10ml Oral Dispensing Syringe Clear w/Tip Cap(Gasket type, bulk,non-sterile
DI: 00810018097929
·
Model: 21010GCNSB
·
Sol-Millennium Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- SOL-M 10ml Oral Dispensing Syringe Clear w/Tip Cap(Gasket type, bulk,non-sterile
- Primary DI
- 00810018097929
- Version / Model
- 21010GCNSB
- Company Name
- Sol-Millennium Medical, Inc.
- Labeler DUNS
- 069590113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-18
- Public Version
- 3
- Public Version Date
- 2025-12-25
- Public Version Status
- Update
- Public Device Record Key
- b607b03a-7aca-419a-9707-6489e4e36367
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYX | Dispenser, Liquid Medication | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65823 | Non-ISO80369-3-standardized oral syringe, single-use | A manual device consisting of a calibrated hollow barrel (cylinder) and a moveable plunger intended for the administration of oral medication. The tip is not formatted according to the standard for small-bore connectors for enteral applications (ISO 80369-3) [i.e., not ENFit], however the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810018097912 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00810018097929 | GS1 | ||||
| Package | 00810018097936 | GS1 | Case | 500 | In Commercial Distribution |
Customer Contacts
- Phone
- 833-637-0857
- [email protected]