Identity
- Trade Name
- RL 1200 Waste Bottle Kit FDA UDI
- Generic Name
- Contaminated waste container FDA UDI
- Device Name
- Waste Bottle Kit. An in vitro diagnostics device for use on the RAPIDLab® 1200 series analyzer. FDA UDI
- Model / Reference
- 10324896 FDA UDI
- Description
- Waste Bottle Kit. An in vitro diagnostics device for use on the RAPIDLab® 1200 series analyzer. FDA UDI
Identifiers
- Catalog Number
- 6641057 FDA UDI
- Primary DI / UDI-DI
- 00630414515144 FDA UDI
- 510(k) Number
- K934907 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Contaminated waste container FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Contaminated waste container
RL 1200 Waste Bottle Kit by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K934907 also covers:
- Ready Sensor™ GOLD Calcium Sensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Glucose Biosensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Glucose Biosensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics
- TB1 pO2/pCO2 Test/Blank Sensor — Siemens Healthcare Diagnostics
- TB2 pH/Na+ Test/Blank Sensor — Siemens Healthcare Diagnostics
- TB3 K+/Ca++/Cl- Test/Blank Sensor — Siemens Healthcare Diagnostics
- TB5 Ref Test/Blank Sensor — Siemens Healthcare Diagnostics
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 4c4b6ebe-ccf4-45eb-9fea-1c112527e1fa 36 fields · synced Jun 8, 2026