Identity
- Trade Name
- RAPIDPOINT® 350 Sampler Module FDA UDI
- Generic Name
- Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
- Device Name
- RAPIDPOINT® 350 Sampler Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 350 analyzer FDA UDI
- Model / Reference
- 10375810 FDA UDI
- Description
- RAPIDPOINT® 350 Sampler Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 350 analyzer FDA UDI
Identifiers
- Catalog Number
- 10375810 FDA UDI
- Primary DI / UDI-DI
- 00630414566313 FDA UDI
- 510(k) Number
- K021515 FDA UDI
- FDA Product Code
- JFP FDA UDIGKF FDA UDICHL FDA UDIJGS FDA UDICEM FDA UDI
- GMDN Term
- Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1145 FDA UDI864.5600 FDA UDI862.1120 FDA UDI862.1665 FDA UDI862.1600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Blood gas/haemoximetry analyser IVD, point-of-care
The RAPIDPOINT 350 Sampler Module is a reliable and accurate point-of-care device for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2), and/or partial pressure of carbon dioxide (pCO2), as well as the calculation of other blood gas and co-oximetry parameters. This implantable device is designed to be used by health professionals at the point-of-care or laboratory settings.
Similar devices
Also classified as Blood gas/haemoximetry analyser IVD, point-of-care.
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
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- Stat Profile — NOVA BIOMEDICAL CORPORATION · Class II
- 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.
- RAPIDChem® 700, RAPIDPoint® 340 Trouble shooting kit — Siemens Healthcare Diagnostics
- RAPIDPOINT® 340 Reagent Module — Siemens Healthcare Diagnostics
- RAPIDPOINT® 340 Sampler Module — Siemens Healthcare Diagnostics
- RAPIDPOINT® 340 Sensor Module — Siemens Healthcare Diagnostics
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 88e263f4-beb1-4cac-bc46-186f1b242b62 36 fields · synced Jul 8, 2026