Identity
- Trade Name
- ExSpiron FDA UDI
- Generic Name
- Monitoring spirometer, electrical FDA UDI
- Device Name
- Noninvasive, insulated, electrical cable designed to connect the ExSpiron Monitor to the ExSpiron PadSet. FDA UDI
- Model / Reference
- Patient Cable, 8' FDA UDI
- Description
- Noninvasive, insulated, electrical cable designed to connect the ExSpiron Monitor to the ExSpiron PadSet. FDA UDI
Identifiers
- Catalog Number
- RMI-51130 FDA UDI
- Primary DI / UDI-DI
- 00851540007017 FDA UDI
- FDA Product Code
- BZQ FDA UDIBZK FDA UDI
- GMDN Term
- Monitoring spirometer, electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 FDA UDI868.1850 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
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: Monitoring spirometer, electrical
ExSpiron by Respiratory Motion, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Respiratory Motion, Inc.
Sources (1)
- FDA UDI e319fb3e-6294-49fb-8c59-a37d1ab85dd4 36 fields · synced Jun 8, 2026