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Accutron Inc.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 53035-9Model Nasal HoodRef 33035-12Ref 53037-12Ref 32007EUModel Scavenging CircuitRef 56200-ADJS-UKModel Digital FlowmeterRef 35300Ref 44000-INTModel Gas ManifoldRef 27679Ref 35500Ref 53037-16Ref 33016-2Ref 25592Ref 33035-16-CAPRef 26400-4CRef 33035-14-CAPRef 23799-FRUModel Analog FlowmeterRef 56600-INTRef 36300-PEURef 33017-10Ref 33016-15Ref 26400-WA
by Accutron
Identity
- Trade Name
- Accutron Inc. EUDAMEDFlowmeter, Digital FlexMount, Wall Arm FDA UDISample, ClearView Triple Pack FDA UDIAxess Mask, Small Bubblegum, 24 Pk FDA UDIHood, Small Orange, 24 Pack FDA UDIDigital Ultra Package C ADJS, UK FDA UDI4 Cylinder, International Adjustable FDA UDIUltra PC % Package D, PEU FDA UDIHood, Med Peach, 24 Pack FDA UDIFRU, Vacuum Tubing 1.5' FDA UDIHood, Med Variety 2 FDA UDIMatrix Adaptor (OHMEDA) FDA UDIHood, ClearView Adult, Bubblegum 12 Pk FDA UDIDigital Ultra Flushmount Package G, INT FDA UDIAxess Mask, Medium Unscented, 24 Pk FDA UDIAxess Mask, Small Mint, 24 Pk FDA UDIEU Scavenging Circuit II FDA UDIFRU, Gauge Newport Int O2 FDA UDIAdaptor, PIP Hood To ClearView FDA UDIClearView Nasal Mask and Capnography Bundle – Adult Fresh Mint (pkg. of 12) FDA UDIClearView Nasal Mask and Capnography Bundle – Adult French Vanilla (pkg. of 12) FDA UDIFlowmeter, Digital Flexmount, 4 Cylinder FDA UDI
- Generic Name
- Oxygen/air/nitrous oxide breathing gas mixer FDA UDIAnaesthesia face mask, single-use FDA UDIGas cylinder holder FDA UDIAnaesthesia workstation gas scavenger FDA UDIAnaesthesia face mask, reusable FDA UDI
- Device Name
- Digital gas mixer FDA UDIMedical gas mixer FDA UDI
- Model / Reference
- Nasal Hood EUDAMED53035-9 EUDAMEDFDA UDI26400-WA EUDAMEDFDA UDI27679 EUDAMEDFDA UDI53037-12 EUDAMEDFDA UDI33017-10 EUDAMEDFDA UDI56200-ADJS-UK EUDAMEDFDA UDI44000-INT EUDAMEDFDA UDI36300-PEU EUDAMEDFDA UDI33016-15 EUDAMEDFDA UDI25592 EUDAMEDFDA UDI33016-2 EUDAMEDFDA UDI35300 EUDAMEDFDA UDI33035-12 EUDAMEDFDA UDI56600-INT EUDAMEDFDA UDI53037-16 EUDAMEDFDA UDI32007EU EUDAMEDFDA UDI23799-FRU EUDAMEDFDA UDI35500 EUDAMEDFDA UDI33035-16-CAP EUDAMEDFDA UDI33035-14-CAP EUDAMEDFDA UDI26400-4C EUDAMEDFDA UDIScavenging Circuit EUDAMEDDigital Flowmeter EUDAMEDGas Manifold EUDAMEDAnalog Flowmeter EUDAMED
- Description
- Digital gas mixer FDA UDIMedical gas mixer FDA UDI
Identifiers
- Catalog Number
- 26400-WA FDA UDI27679 FDA UDI53037-12 FDA UDI33017-10 FDA UDI56200-ADJS-UK FDA UDI44000-INT FDA UDI36300-PEU FDA UDI33016-15 FDA UDI25592 FDA UDI33016-2 FDA UDI35300 FDA UDI33035-12 FDA UDI56600-INT FDA UDI53035-9 FDA UDI53037-16 FDA UDI32007EU FDA UDI23799-FRU FDA UDI35500 FDA UDI33035-16-CAP FDA UDI33035-14-CAP FDA UDI26400-4C FDA UDI
- Primary DI / UDI-DI
- 00813830026702 EUDAMEDFDA UDI00813830025149 EUDAMEDFDA UDI00813830023947 EUDAMEDFDA UDI00813830026740 EUDAMEDFDA UDI00813830025828 EUDAMEDFDA UDI00813830028836 EUDAMEDFDA UDI00813830026276 EUDAMEDFDA UDI00813830025453 EUDAMEDFDA UDI00813830025767 EUDAMEDFDA UDI00813830020458 EUDAMEDFDA UDI00813830025781 EUDAMEDFDA UDI00813830022391 EUDAMEDFDA UDI00813830025927 EUDAMEDFDA UDI00813830027709 EUDAMEDFDA UDI00813830026757 EUDAMEDFDA UDI00813830021332 EUDAMEDFDA UDI00813830026993 EUDAMEDFDA UDI00813830023954 EUDAMEDFDA UDI00813830028744 EUDAMEDFDA UDI00813830028737 EUDAMEDFDA UDI00813830025132 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813830026702 EUDAMEDB-00813830025927 EUDAMEDB-00813830026740 EUDAMEDB-00813830021332 EUDAMEDB-00813830028836 EUDAMEDB-00813830022391 EUDAMEDB-00813830026276 EUDAMEDB-00813830023947 EUDAMEDB-00813830023954 EUDAMEDB-00813830026757 EUDAMEDB-00813830025781 EUDAMEDB-00813830020458 EUDAMEDB-00813830028744 EUDAMEDB-00813830025132 EUDAMEDB-00813830028737 EUDAMEDB-00813830026993 EUDAMEDB-00813830027709 EUDAMEDB-00813830025453 EUDAMEDB-00813830025828 EUDAMEDB-00813830025767 EUDAMEDB-00813830025149 EUDAMED
- FDA Product Code
- BSZ FDA UDIKHA FDA UDIBXH FDA UDIBYX FDA UDICBN FDA UDI
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMEDR020199 BREATHING CIRCUITS AND KITS - OTHER EUDAMEDZ1203010101 ANAESTHESIA DEVICES EUDAMEDZ1203010180 ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Oxygen/air/nitrous oxide breathing gas mixer FDA UDIAnaesthesia face mask, single-use FDA UDIGas cylinder holder FDA UDIAnaesthesia workstation gas scavenger FDA UDIAnaesthesia face mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass IIb EUDAMEDClass II FDA UDIClass I FDA UDI
- Regulation Number
- 868.5160 FDA UDI868.5590 FDA UDI868.2610 FDA UDI868.5860 FDA UDI868.5430 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDIFDA 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
EUDAMEDEUDAMED
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 UDIFDA UDI
Lot / Batch Number
No
FDA UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Anaesthesia face mask, single-use
Accutron Inc. by Accutron — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Anaesthesia face mask, single-use.
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- King Mask — Ambu A/S · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813830026702 | 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
- Accutron
- EUDAMED SRN
- US-MF-000009363
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (42)
- EUDAMED 6300540a-a4ee-42bd-b2c5-a0f9221d1205 61 fields · synced Sep 18, 2026
- FDA UDI 87fb75f3-8787-4bc9-938f-4c75b4d77882 35 fields · synced May 25, 2026
- FDA UDI d6925a67-6a3e-4619-8c25-edd1e9f03347 33 fields · synced May 25, 2026
- FDA UDI 837f0764-c474-4d46-8b23-3d9994610d42 33 fields · synced May 27, 2026
- FDA UDI db3200e3-5ea5-4401-bc6c-76c8eb76c383 33 fields · synced May 27, 2026
- FDA UDI b50ba0a9-4ddd-4158-8249-5612a453a8db 34 fields · synced May 29, 2026
- FDA UDI 0a3aa623-f072-4331-aa62-3274d63262ec 33 fields · synced May 29, 2026
- FDA UDI 45f91b3e-2874-4fc3-a727-29fc2d404931 34 fields · synced May 30, 2026
- FDA UDI 1deb56fc-8d89-407f-b3ed-3c8531b6821d 33 fields · synced May 30, 2026
- FDA UDI f6738f99-fadd-4427-ba18-717ffc7069ee 33 fields · synced May 30, 2026
- FDA UDI 89f07145-e09d-4d2b-a706-cadda9290139 33 fields · synced May 30, 2026
- FDA UDI eedeed96-d2a4-4dce-9410-dd1c21d3a243 34 fields · synced May 30, 2026
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- FDA UDI 53802eda-73e4-4595-83e3-cf60f5696a49 34 fields · synced May 30, 2026
- FDA UDI 09fdbd19-aaa1-46e5-a98b-5985ab5060cb 33 fields · synced May 30, 2026
- FDA UDI 6f4489f2-4330-4889-9478-bb7e2a237a10 33 fields · synced May 30, 2026
- FDA UDI a61ec459-b17a-4074-a2e7-1ee6b110fbcb 34 fields · synced May 30, 2026
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- FDA UDI 28b7074d-3138-4c12-a4b2-e015ebf745f7 33 fields · synced May 30, 2026
- FDA UDI c0d92da4-0576-41b1-84fa-19563c44c883 33 fields · synced May 30, 2026
- FDA UDI 1ac61d71-e7fc-487f-a31a-5d61173af8b3 33 fields · synced May 30, 2026
- FDA UDI 4dc3df82-dc97-4ba9-9689-deda77ca4fd0 35 fields · synced May 30, 2026
- EUDAMED a99515e9-7478-47bf-82f0-89783fa5bb3e 61 fields · synced Jul 8, 2026
- EUDAMED 7e76663d-cfca-4e0c-b1f5-a846d6fe0df3 61 fields · synced Jul 9, 2026
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- EUDAMED 85adc198-42aa-4c3a-a5c1-76878f8a4540 61 fields · synced Jul 17, 2026
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- EUDAMED 11ba5c22-f800-4ef4-887a-d62e391158ef 61 fields · synced Jul 21, 2026
- EUDAMED 7b56a367-0cb6-4a81-a1b9-8e5b0037374e 61 fields · synced Jul 22, 2026
- EUDAMED 27f64f13-8ed8-44ad-b553-fadd887f0a41 61 fields · synced Jul 23, 2026
- EUDAMED 2180c502-b91a-4d9a-9554-d8bb5f131e84 61 fields · synced Jul 25, 2026
- EUDAMED 7e10e527-70e8-4273-8207-2a0afe598616 61 fields · synced Jul 26, 2026
- EUDAMED 4398d77b-afa4-48d8-ab4e-f0a27eca32ff 61 fields · synced Jul 31, 2026
- EUDAMED 7ed69dff-4aac-41ea-88cc-dbc115c9d301 61 fields · synced Jul 31, 2026
- EUDAMED 7854faff-e25d-4c8f-839e-c619417cba31 61 fields · synced Aug 1, 2026
- EUDAMED 6e31ccf4-3220-498c-8b09-5532390b9058 61 fields · synced Sep 18, 2026