Teleflex/Hudson RCI

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: Teleflex/Hudson RCI FDA UDI
Generic Name: Non-rebreathing valve, single-use FDA UDI
Device Name: .5 Ltr. Hyperinflation Bag System FDA UDI
Model / Reference: 2700-205 FDA UDI
Description: .5 Ltr. Hyperinflation Bag System FDA UDI

Identifiers

Catalog Number: 2700-205 FDA UDI
Primary DI / UDI-DI: 10080196003648 FDA UDI
510(k) Number: K925591 FDA UDI
FDA Product Code: BZR FDA UDI
GMDN Term: Non-rebreathing valve, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5330 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Total Volume — 0.5 Liter FDA UDI

Category: Non-rebreathing valve, single-use

Teleflex/Hudson RCI by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Non-rebreathing valve, single-use.

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Cleared under the same submission

K925591 also covers:

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: Medline Industries, Inc.

Sources (1)

FDA UDI d866ef25-2b9b-49c2-9ed1-e72c51016a4c 37 fields · synced Jun 8, 2026