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SOL-M™ Blunt Fill Needle with 5 Micron Filter
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- SOL-M™ Blunt Fill Needle with 5 Micron Filter FDA UDI
- Generic Name
- Medication transfer needle, non-filtering/non-vented FDA UDI
- Device Name
- Used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. systems and pre-slit septums covering injection sites. FDA UDI
- Model / Reference
- 110022 FDA UDI
- Description
- Used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. systems and pre-slit septums covering injection sites. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818392015294 FDA UDI
- FDA Product Code
- GAA FDA UDI
- GMDN Term
- Medication transfer needle, non-filtering/non-vented FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 18 Gauge FDA UDILength — 40 Millimeter FDA UDI
Category: Medication transfer needle, non-filtering/non-vented
SOL-M™ Blunt Fill Needle with 5 Micron Filter by Sol-Millennium Medical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sol-Millennium Medical, Inc.
Sources (2)
- FDA UDI eed731bc-4a14-4ce3-8fb8-5f16f59fb312 35 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026