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Litetouch Large Mask- Row
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1083783Model LiteTouch
Identity
- Trade Name
- LITETOUCH LARGE MASK- ROW EUDAMEDLiteTouch EUDAMEDFDA UDI
- Generic Name
- Medicine chamber spacer, reusable FDA UDI
- Device Name
- LiteTouch Face Mask EUDAMEDLiteTouch Large Mask , ROW. FDA UDI
- Model / Reference
- 1083783 EUDAMEDLiteTouch EUDAMED00 FDA UDI
- Description
- LiteTouch Large Mask , ROW. FDA UDI
Identifiers
- Catalog Number
- 1083783 FDA UDI
- Primary DI / UDI-DI
- 00383730000794 EUDAMEDFDA UDI
- Basic UDI-DI
- 038373BM262XD EUDAMEDB-00383730000794 EUDAMED
- FDA Product Code
- CAF FDA UDI
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
- GMDN Term
- Medicine chamber spacer, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Market of Registration
- Belgium EUDAMEDAustria 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
EUDAMEDEUDAMED
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Category: Anaesthesia face mask, single-use
Litetouch Large Mask- Row by Respironics, Inc. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
- Ventlab — Ventlab Corp. · Class I
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- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- Vital Signs™ — Airlife, Inc. · Class I
- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 038373BM262XD | Class I | Active |
| EUDAMED | European Union | CE/MDR | 038373BM262XD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (3)
- EUDAMED a95f09dd-1e21-406b-b7d1-bc993855c430 61 fields · synced Jul 28, 2026
- FDA UDI 1505eb31-6644-4e35-bc50-7f8ea06eebf0 35 fields · synced May 29, 2026
- EUDAMED 56268062-4dcf-4451-b880-60bd9851a6b4 61 fields · synced Jul 28, 2026