Identity
- Trade Name
- BPR Medical EUDAMEDFDA UDIExhalation Valve for use with Face Mask EUDAMED
- Generic Name
- Demand valve FDA UDI
- Device Name
- Ultraflow Exhalation Valve for use with Face Mask (1) EUDAMEDDemand Valve EUDAMEDThe exhalation valve is a single patient use disposable accessory for use with the oxygen demand valve FDA UDI
- Model / Reference
- 828-0041 EUDAMEDExhalation valve FDA UDI
- Description
- The exhalation valve is a single patient use disposable accessory for use with the oxygen demand valve FDA UDI
Identifiers
- Catalog Number
- 828-0003 FDA UDI
- Primary DI / UDI-DI
- 05060274502698 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060274502698 EUDAMED5060274500096D EUDAMED
- 510(k) Number
- K082345 FDA UDI
- FDA Product Code
- CBP FDA UDI
- EMDN Code
- R040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMEDR9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Demand valve FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5870 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Secretion suction kit
BPR Medical by Bpr Medical Limited — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Secretion suction kit.
- EXMOOR — Exmoor Plastics , Ltd. · Class I
- Suction Catheter Kits, Disposable — Dynarex Corp. · Class I
- AirLife™ Mini-Filter/S, Disposable — AirLife Finland Oy · Class IIa
- HITECARE — Ningbo Boya Medical Equipment Co., Ltd · Class IIa
- RespVac™ — CUTTING EDGE HC BRANDS LLC · Class I
- Breathing Filter — Ningbo Luke Medical Devices Co.,LTD · Class IIa
- EXMOOR — Exmoor Plastics , Ltd. · Class I
- Bioseal Inc. — BIOSEAL · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05060274502698 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05060274502698 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BPR Medical Limited
- EUDAMED SRN
- GB-MF-000003347
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED ff4440a0-2e86-4511-88c7-883e256e216e 61 fields · synced Jul 13, 2026
- EUDAMED 918fdde6-7f3e-4b7b-8cf9-05c47cd6f8c1 61 fields · synced May 17, 2026
- FDA UDI 99c1c73f-c597-4c5d-8f57-6f2bb6ebac53 36 fields · synced May 30, 2026