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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
Incentive spirometer FDA UDI
Device Name
VOLUMETRIC EXERCISER For Maintaining and Improving Inspiratory Volume and Respiratory Fitness FDA UDI
Model / Reference
IPN049318 FDA UDI
IPN045543 FDA UDI
Description
VOLUMETRIC EXERCISER For Maintaining and Improving Inspiratory Volume and Respiratory Fitness FDA UDI

Identifiers

Catalog Number
8884719025 FDA UDI
Primary DI / UDI-DI
14026704630193 FDA UDI
04026704597017 FDA UDI
510(k) Number
K801199 FDA UDI
FDA Product Code
BWF FDA UDI
GMDN Term
Incentive spirometer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5690 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Incentive spirometer

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

Similar devices

Also classified as Incentive spirometer.

Cleared under the same submission

K801199 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (2)

  • FDA UDI f3193082-db0c-4389-84a9-6a9b2b56a520 37 fields · synced Jun 1, 2026
  • FDA UDI 3b3f2659-583a-4bae-bad5-37828a92f08f 37 fields · synced May 26, 2026