Identity
- Trade Name
- DART-Reach FDA UDI
- Generic Name
- Atomizer, non-ventilatory FDA UDI
- Device Name
- DART EUDAMED
- Model / Reference
- REACH700 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841470100322 EUDAMEDFDA UDI
- Basic UDI-DI
- 08414701DARTGT EUDAMED
- 510(k) Number
- K070596 FDA UDI
- FDA Product Code
- CCT 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 EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5170 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 218 Millimeter FDA UDI
Category: Atomizer, non-ventilatory
DART-Reach by Pulmodyne Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pulmodyne Inc.
Sources (2)
- FDA UDI a9fb9acf-cc17-4f8e-af28-1e265dedf169 34 fields · synced Aug 2, 2026
- EUDAMED 3a4488b1-8173-49df-ac40-092626682b03 61 fields · synced Aug 2, 2026