← Back to catalogue
Spirit
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 11897386Ref 13040950Ref 11741322510(k) K050153Ref 11741277
by CAIRE Inc.
Identity
- Trade Name
- Spirit EUDAMED
- Device Name
- FNL SPIRIT 1200T TF PB F 5LPM EUDAMEDSpirit EUDAMED
- Model / Reference
- 11897386 EUDAMED13040950 EUDAMED11741322 EUDAMED11741277 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M766118973860 EUDAMEDM766130409500 EUDAMEDM766117413220 EUDAMEDM766117412770 EUDAMED
- Basic UDI-DI
- B-M766118973860 EUDAMEDB-M766130409500 EUDAMEDB-M766117413220 EUDAMEDB-M766117412770 EUDAMED
- 510(k) Number
- K050153 FDA 510(k)
- FDA Product Code
- BYJ FDA 510(k)
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5655 FDA 510(k)
- Regulation Number
- 868.5655 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
Spirit by Caire Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary function analysis system, adult.
- Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
- VISCOFLU — PHARMA LINE Srl · Class IIb
- Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
- Vyaire — Jaeger Medical GmbH · Class II
- AEROCHAMBER PLUS FLOW-VU — TRUDELL MEDICAL INTERNATIONAL · Class I
- Shape II System Refurbished — Shape Medical Systems, Inc. · Class II
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050153 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-M766118973860 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CAIRE Inc.
- EUDAMED SRN
- US-MF-000013030
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (5)
- EUDAMED 648b32ce-0df1-4811-8fdc-785b9a6b0ffa 61 fields · synced Jul 29, 2026
- EUDAMED 2f871bfd-c6c4-4d77-983f-49f78f89c73b 61 fields · synced May 16, 2026
- EUDAMED 5f89c559-6523-43d8-8544-72ab5947788d 61 fields · synced May 17, 2026
- FDA 510(k) K050153 24 fields · synced May 18, 2026
- EUDAMED 9ad91617-3747-4b74-830a-b73bd51d6703 61 fields · synced Jul 18, 2026