← Back to catalogue
Coda® Aero®
EUDAMEDFDA UDIClass I (EU MDR)
Ref GCAF-002Ref CAFK-900Ref GCAF-001Ref GCAF-702
Identity
- Trade Name
- Coda® Aero® EUDAMEDCoda® FDA UDI
- Generic Name
- Non-respiratory device ambient air filter FDA UDI
- Device Name
- Coda® Aero® 400/500 Quarterly, 2pk EUDAMEDCodaAir ® 900: Shirtbox Filter EUDAMEDCoda® Aero® 400/500 Quarterly, 1pk EUDAMEDCoda Aero 400/500 Quarterly Filter (single) FDA UDI
- Model / Reference
- GCAF-002 EUDAMEDCAFK-900 EUDAMEDGCAF-001 EUDAMEDFDA UDIGCAF-702 EUDAMED
- Description
- Coda Aero 400/500 Quarterly Filter (single) FDA UDI
Identifiers
- Catalog Number
- GCAF-001 FDA UDI
- Primary DI / UDI-DI
- 00815965021577 EUDAMEDD-CAFK-9006W EUDAMED00815965021195 EUDAMEDFDA UDID-GCAF-7026E EUDAMED
- Basic UDI-DI
- B-00815965021577 EUDAMEDB-CAFK-9006W EUDAMEDB-00815965021195 EUDAMEDB-GCAF-7026E EUDAMED
- 510(k) Number
- K001486 FDA UDI
- FDA Product Code
- MQG FDA UDI
- EMDN Code
- W02070304 CHEMICAL FILTRATION AIR CLOSETS EUDAMED
- GMDN Term
- Non-respiratory device ambient air filter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6120 FDA UDI
- Market of Registration
- Northern Ireland 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Coda® Aero® by LifeGlobal Group, LLC — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00815965021577 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LifeGlobal Group, LLC
- EUDAMED SRN
- US-MF-000015291
- Authorised Representative
- CooperSurgical Distribution B.V. NL-AR-000000059
Sources (5)
- EUDAMED ab5808c4-933f-4d4c-a2c8-9562ca1fbdf1 61 fields · synced Jul 26, 2026
- EUDAMED badb9884-af0e-4127-8991-63790ca186e9 61 fields · synced May 18, 2026
- EUDAMED 4ea88b86-02a7-4e31-9e6f-dde1b52073a6 61 fields · synced May 18, 2026
- EUDAMED c0c72d99-5eaa-4718-8502-809acd64f0be 61 fields · synced May 19, 2026
- FDA UDI c13f8bb7-c8d1-4c0f-8655-1fa62a28c6d7 36 fields · synced May 29, 2026