Identity
- Trade Name
- Microstream FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- MICROSTREAM VITALINE H SET ADULT/PEDIATRIC 1UN FDA UDI
- Model / Reference
- 015707_RMS1 FDA UDI
- Description
- MICROSTREAM VITALINE H SET ADULT/PEDIATRIC 1UN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521552029 FDA UDI
- 510(k) Number
- K980327 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Gas-sampling/monitoring respiratory tubing, single-use
Microstream by Oridion Medical 1987 Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Gas-sampling/monitoring respiratory tubing, single-use.
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Cleared under the same submission
K980327 also covers:
- Microstream — ORIDION MEDICAL 1987 LTD.
- Microstream — ORIDION MEDICAL 1987 LTD.
- Microstream — ORIDION MEDICAL 1987 LTD.
- Microstream — ORIDION MEDICAL 1987 LTD.
- Microstream — ORIDION MEDICAL 1987 LTD.
- Surestream — ORIDION MEDICAL 1987 LTD.
- Surestream — ORIDION MEDICAL 1987 LTD.
- Ventline — ORIDION MEDICAL 1987 LTD.
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
- Oridion Medical 1987 Ltd.
Sources (1)
- FDA UDI a61e42f6-af4b-4cfe-a0ef-b127322d3d03 35 fields · synced Jun 8, 2026