Identity
- Trade Name
- DART FDA UDI
- Generic Name
- Atomizer, non-ventilatory FDA UDI
- Device Name
- DART EUDAMED
- Model / Reference
- DART100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841470100308 EUDAMEDFDA UDI
- Basic UDI-DI
- 08414701DARTGT EUDAMED
- FDA Product Code
- CCQ FDA UDI
- EMDN Code
- Z1399 NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Atomizer, non-ventilatory FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5640 FDA UDI
- Market of Registration
- Lithuania 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Atomizer, non-ventilatory
Dart by Pulmodyne Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pulmodyne Inc.
Sources (2)
- FDA UDI fa36aec8-4b4e-4883-96b4-b64c64b3432e 32 fields · synced Jun 19, 2026
- EUDAMED 280f02a8-ddfa-4bf8-ad8c-2baf8c931f1b 61 fields · synced Jun 19, 2026