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PM5300 Series Blender, Air/O2, Low Flow
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref PM5300 Series Blender, Air/O2, Low Flow510(k) K053232
Identity
- Trade Name
- PM5300 Series Blender, Air/O2, Low Flow EUDAMEDPrecision Medical Blender FDA UDI
- Generic Name
- Oxygen/air breathing gas mixer, hospital FDA UDI
- Device Name
- PM5300 Series Blender EUDAMEDPM5300 SERIES,BLENDER,AIR/O2,LOW FLOW FDA UDI
- Model / Reference
- PM5300 Series Blender, Air/O2, Low Flow EUDAMEDPM5300 FDA UDI
- Description
- PM5300 SERIES,BLENDER,AIR/O2,LOW FLOW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855887006016 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00855887006016 EUDAMED
- 510(k) Number
- K053232 FDA UDI
- FDA Product Code
- BZR FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Oxygen/air breathing gas mixer, hospital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5330 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary function analysis system, adult
PM5300 Series Blender, Air/O2, Low Flow by Precision Medical, Inc. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
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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 | K053232 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00855887006016 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Precision Medical Inc
- EUDAMED SRN
- US-MF-000008706
- FDA Applicant
- Precision Medical, Inc.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 7fb90534-37c1-4faf-9758-31896f122c62 85 fields · synced Oct 6, 2026
- FDA UDI 3bffd693-9e8c-4e75-b0e5-a85690000f8d 35 fields · synced May 30, 2026
- EUDAMED 7fb90534-37c1-4faf-9758-31896f122c62-1 61 fields · synced Jun 9, 2026
- FDA 510(k) K053232 1 fields · synced May 18, 2026