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RAPIDChem® 700, RAPIDPoint® 340 Trouble shooting kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- RAPIDChem® 700, RAPIDPoint® 340 Trouble shooting kit FDA UDI
- Generic Name
- Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
- Device Name
- Trouble shooting kit for use with RAPIDChem® 700, RAPIDPoint® 340 systems. FDA UDI
- Model / Reference
- 10317312 FDA UDI
- Description
- Trouble shooting kit for use with RAPIDChem® 700, RAPIDPoint® 340 systems. FDA UDI
Identifiers
- Catalog Number
- 2577729 FDA UDI
- Primary DI / UDI-DI
- 00630414452074 FDA UDI
- 510(k) Number
- K021515 FDA UDI
- FDA Product Code
- JGS FDA UDIJFP FDA UDICHL FDA UDICEM FDA UDIGKF FDA UDI
- GMDN Term
- Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1665 FDA UDI862.1145 FDA UDI862.1120 FDA UDI862.1600 FDA UDI864.5600 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDChem® 700, RAPIDPoint® 340 Trouble shooting kit by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood gas/haemoximetry analyser IVD, point-of-care.
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- i-STAT — Abbott Point of Care Inc. · Class II
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class I
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
Cleared under the same submission
K021515 also covers:
- Bi-Level QC Kit, HCT — Medica Corp.
- Calcium Electrode — Medica Corp.
- Daily Cleaning Solution Kit — Medica Corp.
- Potassium Electrode — Medica Corp.
- Reagent Module — Medica Corp.
- Sodium Electrode — Medica Corp.
- pH/pCO2/pO2/Na/K/Ca Analyzer — Medica Corp.
- pH/pCO2/pO2/Na/K/Ca Analyzer — Medica Corp.
- RAPIDPOINT® 340 Reagent Module — Siemens Healthcare Diagnostics
- RAPIDPOINT® 340 Sampler Module — Siemens Healthcare Diagnostics
- RAPIDPOINT® 340 Sensor Module — Siemens Healthcare Diagnostics
- RAPIDPOINT® 340/350 pO2 Electrode — 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 1ad3960e-b405-4193-853f-a36f0eaf810c 37 fields · synced May 30, 2026