Identity
- Trade Name
- Rocket FDA UDI
- Generic Name
- Suction system filter, microbial FDA UDI
- Device Name
- Rocket Glass Collection Bottle with bung FDA UDI
- Model / Reference
- R28406 FDA UDI
- Description
- Rocket Glass Collection Bottle with bung FDA UDI
Identifiers
- Catalog Number
- R28406 FDA UDI
- Primary DI / UDI-DI
- 05055270984463 FDA UDI
- 510(k) Number
- K000394 FDA UDI
- FDA Product Code
- MQG FDA UDI
- GMDN Term
- Suction system filter, microbial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6120 FDA UDI
- Commercial Distribution
- Not 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
No
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
Rocket by Rocket Medical Plc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K000394 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
- Rocket Medical Plc
Sources (1)
- FDA UDI b05a3f99-323b-4168-a6e7-8254ac5422e1 36 fields · synced May 30, 2026