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Isofluid Surgical Masks
EUDAMEDFDA UDIClass I (EU MDR)
Ref GCILVSFModel Face Masks and ShieldsRef GCICXSRef GCISARef GCIBLSFRef GCIBL100
Identity
- Trade Name
- Isofluid Surgical Masks EUDAMEDIsofluidTM Earloop Mask FDA UDIIsofluid FogFreeTM Earloop Mask FDA UDIIsofluidTM Earloop Mask w/ Secure FitTM FDA UDIIsofluid™ Earloop Mask w/Secure Fit™ Mask Technology FDA UDI
- Generic Name
- Surgical/medical respirator, non-antimicrobial, single-use FDA UDI
- Device Name
- Blue, Bulk Pack-100/box-500/cs FDA UDISapphire, 50/Box FDA UDISapphire, 40/Box FDA UDIBlue, 50/box FDA UDIFacemask, Lavender FDA UDI
- Model / Reference
- Face Masks and Shields EUDAMEDGCILVSF EUDAMEDFDA UDIGCIBL100 EUDAMEDFDA UDIGCISA EUDAMEDFDA UDIGCICXS EUDAMEDFDA UDIGCIBLSF EUDAMEDFDA UDI
- Description
- Blue, Bulk Pack-100/box-500/cs FDA UDISapphire, 50/Box FDA UDISapphire, 40/Box FDA UDIBlue, 50/box FDA UDIFacemask, Lavender FDA UDI
Identifiers
- Catalog Number
- GCIBL100 FDA UDIGCISA FDA UDIGCICXS FDA UDIGCIBLSF FDA UDI
- Primary DI / UDI-DI
- 10732224120208 EUDAMEDFDA UDI10732224120116 EUDAMEDFDA UDI10732224120284 EUDAMEDFDA UDI10732224120154 EUDAMEDFDA UDI10732224120123 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224FaceMask&ShieldQM EUDAMED
- Unit of Use DI
- 00732224120201 EUDAMED00732224120157 EUDAMED00732224120287 EUDAMED00732224120126 EUDAMED00732224120119 EUDAMED
- 510(k) Number
- K082258 FDA UDI
- FDA Product Code
- FXX FDA UDI
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
- GMDN Term
- Surgical/medical respirator, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4040 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Isofluid Surgical Masks by Crosstex International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0732224FaceMask&ShieldQM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Crosstex International Inc
- EUDAMED SRN
- US-MF-000009642
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (10)
- EUDAMED 866b02e9-6dc9-4b56-9b98-6eccf670d24a 61 fields · synced Oct 6, 2026
- FDA UDI 7d0aa028-8190-4d47-9480-40ba3caf490c 35 fields · synced May 30, 2026
- FDA UDI 066ad335-e2c5-47e2-9d9a-166724e5a770 35 fields · synced May 30, 2026
- FDA UDI 92d82474-4691-4e21-9efd-f9c1b92f0d9a 35 fields · synced May 30, 2026
- FDA UDI 45ea79c7-b468-43cf-b641-533fef2ae272 35 fields · synced May 30, 2026
- FDA UDI 3bcc6dc8-b0c1-4fb5-bf30-0be023062de7 35 fields · synced May 30, 2026
- EUDAMED 62dd5b2f-1ca9-4253-9829-ca3c680ce57a 61 fields · synced Jul 9, 2026
- EUDAMED 72bfe407-fc14-4ac2-bc6a-32429d19666a 61 fields · synced Jul 21, 2026
- EUDAMED e6da34e6-97b0-4590-85db-5309dcecf332 61 fields · synced Jul 24, 2026
- EUDAMED b607b11a-cee6-4738-b96c-86e79c218c59 61 fields · synced Aug 4, 2026