Identity
- Trade Name
- PEGASUS FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Device Name
- NEBULIZER HEATER ADAPTER GASKET FDA UDI
- Model / Reference
- P70100 FDA UDI
- Description
- NEBULIZER HEATER ADAPTER GASKET FDA UDI
Identifiers
- Catalog Number
- P70100 FDA UDI
- Primary DI / UDI-DI
- 00612223701017 FDA UDI
- 510(k) Number
- K880473 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Heated respiratory humidifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 1.675 Inch FDA UDIHeight — .0625 Inch FDA UDIWeight — .01 Pound FDA UDI
Category: Heated respiratory humidifier
Pegasus by Pegasus Research Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Heated respiratory humidifier.
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- Fisher and Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
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- A Series Heated Humidifier — Respironics, Inc. · Class II
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Cleared under the same submission
K880473 also covers:
- CURAPLEX — Pegasus Research Corp.
- CURAPLEX — Pegasus Research Corp.
- CURAPLEX — Pegasus Research Corp.
- CURAPLEX — Pegasus Research Corp.
- CURAPLEX — Pegasus Research Corp.
- CURAPLEX — Pegasus Research Corp.
- CURAPLEX — Pegasus Research Corp.
- PEGASUS — Pegasus Research Corp.
- PEGASUS — Pegasus Research Corp.
- PEGASUS — Pegasus Research Corp.
- PEGASUS — Pegasus Research Corp.
- PEGASUS — Pegasus Research Corp.
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 63c01dd9-9f3c-4f06-8ba9-684ecf7fc6db 36 fields · synced May 30, 2026