Identity
- Trade Name
- Ultima Nasal Cannula, Pediatric FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- Tubing used to detect airflow in sleep studies. FDA UDI
- Model / Reference
- 8582PED-50 FDA UDI
- Description
- Tubing used to detect airflow in sleep studies. FDA UDI
Identifiers
- Catalog Number
- 8582PED-50 FDA UDI
- Primary DI / UDI-DI
- B1408582PED501 FDA UDI
- FDA Product Code
- CAT FDA UDI
- GMDN Term
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gas-sampling/monitoring respiratory tubing, single-use
Ultima Nasal Cannula, Pediatric by Braebon Medical Corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gas-sampling/monitoring respiratory tubing, single-use.
- NomoLine™ Infant/Neonatal Airway Adapter Set with Luer — MASIMO CORPORATION · Class II
- HydroFit Hydrocolloid Adhesive Housing, Oval Extra, 30pk — FREUDENBERG MEDICAL, LLC · Class I
- CAPNOGRAPHY CONNECTOR W/10FT LINE + SLIP LUER FILTER — FLEXICARE MEDICAL LIMITED · Class II
- Classic RT 12 White 10F&15M/10F&15M 1.50m — Plastiflex Group NV · Class IIa
- Perma Pure — Perma Pure, LLC · Class II
- PERMA PURE — Perma Pure, LLC · Class II
- Regular Tape Discs, Std, 30 pack — Freudenberg Medical LLC · Class I
- LiteAire BASIC — THAYER MEDICAL CORPORATION · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Braebon Medical Corp.
Sources (2)
- FDA UDI 8110413e-fae8-4960-a88e-80aa94da3337 35 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 1, 2026