Identity
- Trade Name
- PACIFIC MEDICO FDA UDI
- Generic Name
- Inspiratory line humidification chamber, single-use FDA UDI
- Device Name
- 300 ML DISPOSABLE HUMIDIFICATION CHAMBER, WITH AUTO FEED TUBING. 24/CASE FDA UDI
- Model / Reference
- PMC-300AF FDA UDI
- Description
- 300 ML DISPOSABLE HUMIDIFICATION CHAMBER, WITH AUTO FEED TUBING. 24/CASE FDA UDI
Identifiers
- Catalog Number
- PMC-300AF FDA UDI
- Primary DI / UDI-DI
- 00612223321031 FDA UDI
- FDA Product Code
- BTT FDA UDI
- GMDN Term
- Inspiratory line humidification chamber, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5450 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
No
FDA UDI
Category: Inspiratory line humidification chamber, single-use
Pacific Medico by Pegasus Research Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pegasus Research Corp.
Sources (1)
- FDA UDI 73533ab6-bec2-49bc-93b0-0b7320f84878 34 fields · synced May 31, 2026