Hudson RCI

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: Hudson RCI FDA UDI
Generic Name: Pulmonary resuscitator, manual, reusable FDA UDI
Device Name: Manual Resuscitator, Durable, Adult - with Large Resuscitation Mask and Reservoir FDA UDI
Model / Reference: IPN044930 FDA UDI
Description: Manual Resuscitator, Durable, Adult - with Large Resuscitation Mask and Reservoir FDA UDI

Identifiers

Catalog Number: 5345 FDA UDI
Primary DI / UDI-DI: 04026704613625 FDA UDI
FDA Product Code: BTM FDA UDI
GMDN Term: Pulmonary resuscitator, manual, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5915 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Length — 8.27 Inch FDA UDI

Category: Pulmonary resuscitator, manual, reusable

Hudson RCI by Teleflex Incorporated — 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: Teleflex Incorporated

Sources (1)

FDA UDI 06e908eb-9f67-45a6-93bc-8d2f4ea5e707 37 fields · synced Jun 6, 2026