Perma Pure
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ME-070-03-49 Arete Custom ME-070-21FFL EUDAMEDPERMA PURE FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- Nafion™ Tube Dryer, ME Series EUDAMEDArete Custom ME-070-21FFL FDA UDI
- Model / Reference
- Nafion Dryer, ME Series EUDAMEDME-070-03-49 EUDAMEDME Series FDA UDI
- Description
- Arete Custom ME-070-21FFL FDA UDI
Identifiers
- Catalog Number
- ME-070-03-49 FDA UDI
- Primary DI / UDI-DI
- 00840106905614 EUDAMEDFDA UDI
- Basic UDI-DI
- 08401069MESeriesJA EUDAMED
- Direct Marketing DI
- 00840106905614 EUDAMED
- FDA Product Code
- CBQ FDA UDI
- EMDN Code
- R9080 RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Gas-sampling/monitoring respiratory tubing, single-use
Perma Pure by Perma Pure, LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Perma Pure, LLC
Sources (2)
- FDA UDI 622dd574-f775-4ccb-96bf-3607aff37ee9 34 fields · synced Jun 20, 2026
- EUDAMED ee492515-492a-44d9-bc1a-3e28686d4e35 61 fields · synced Jun 20, 2026