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Hudson Rci

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
HUDSON RCI FDA UDI
Generic Name
Nebulizing adaptor FDA UDI
Device Name
NEBULIZER ADAPTOR 028,STERILE,SHELFPAK, FDA UDI
Model / Reference
IPN040617 FDA UDI
Description
NEBULIZER ADAPTOR 028,STERILE,SHELFPAK, FDA UDI

Identifiers

Catalog Number
031-28F FDA UDI
Primary DI / UDI-DI
04026704391899 FDA UDI
510(k) Number
K153010 FDA UDI
FDA Product Code
CAF FDA UDI
GMDN Term
Nebulizing adaptor 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

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Nebulizing adaptor

Hudson Rci by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nebulizing adaptor.

Cleared under the same submission

K153010 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI fbadc0dd-79f0-4ef0-9438-34bf7a9567d5 36 fields · synced May 30, 2026