Identity
- Trade Name
- Spectrum, Inc. FDA UDI
- Generic Name
- Syringe filter, clinical FDA UDI
- Device Name
- Hydrophilic Syringe Tip Filter - DG2M-330-100, Non- Sterile FDA UDI
- Model / Reference
- DG2M-330 FDA UDI
- Description
- Hydrophilic Syringe Tip Filter - DG2M-330-100, Non- Sterile FDA UDI
Identifiers
- Catalog Number
- DG2M-330-100 FDA UDI
- Primary DI / UDI-DI
- 00850301007600 FDA UDI
- 510(k) Number
- K852996 FDA UDI
- FDA Product Code
- FPB FDA UDI
- GMDN Term
- Syringe filter, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Syringe filter, clinical
Spectrum, Inc. by Spectrum Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Syringe filter, clinical.
- .20 Micron Filter — Hurricane Medical · Class I
- Advanced Instruments RBC Reagent Filtration Kit — Advanced Instruments, LLC · Class II
- Epimed — EPIMED INTERNATIONAL, INC. · Class II
- Spectrum, Inc. — Spectrum Co. · Class II
Cleared under the same submission
K852996 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spectrum Co.
Sources (1)
- FDA UDI e6318e9b-fab7-4395-9e13-abf8a682e52b 36 fields · synced May 30, 2026