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BiPAP S/T C-Series

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name
BiPAP S/T C-Series FDA UDI
Generic Name
Portable electric ventilator FDA UDI
Device Name
BiPAP S/T C Series, 30cm, International, Italy FDA UDI
Model / Reference
BiPAP S/T C Series, 30cm, INTL, IT FDA UDI
Description
BiPAP S/T C Series, 30cm, International, Italy FDA UDI

Identifiers

Catalog Number
IT1061X FDA UDI
Primary DI / UDI-DI
00606959039148 FDA UDI
510(k) Number
K102465 FDA UDI
FDA Product Code
MNS FDA UDI
GMDN Term
Portable electric ventilator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5895 FDA UDI
Commercial Distribution
Not 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

BiPAP S/T C-Series by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K102465 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Respironics, Inc.

Sources (1)

  • FDA UDI e45d055e-149f-4ce8-bf9a-63cb90ae9703 38 fields · synced May 31, 2026