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VitalSense

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name
VitalSense FDA UDI
Generic Name
Temperature telemetric monitoring system transmitter FDA UDI
Device Name
Finished Good, VitalSense Temperature Capsule FDA UDI
Model / Reference
VITALSENSE FDA UDI
Description
Finished Good, VitalSense Temperature Capsule FDA UDI

Identifiers

Catalog Number
500-0100-02 FDA UDI
Primary DI / UDI-DI
00606959021648 FDA UDI
510(k) Number
K033534 FDA UDI
FDA Product Code
FLL FDA UDI
GMDN Term
Temperature telemetric monitoring system transmitter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2910 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Temperature telemetric monitoring system transmitter

VitalSense by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Temperature telemetric monitoring system transmitter.

Cleared under the same submission

K033534 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 b9df3132-cc35-4f36-ac74-ee5ad91f93a3 38 fields · synced May 30, 2026