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Criticare

FDA UDI

Class II (US FDA UDI)

by Criticare Technologies Corp.

Identity

Trade Name
Criticare FDA UDI
Generic Name
Multiple vital physiological parameter monitoring system, clinical FDA UDI
Device Name
Monitor with DOX SPO2, NIBP, and HR FDA UDI
Model / Reference
eQuality 506DN FDA UDI
Description
Monitor with DOX SPO2, NIBP, and HR FDA UDI

Identifiers

Primary DI / UDI-DI
B438560DNUS0 FDA UDI
510(k) Number
K091050 FDA UDI
FDA Product Code
DQA FDA UDI
DXN FDA UDI
GMDN Term
Multiple vital physiological parameter monitoring system, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 FDA UDI
870.1130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Multiple vital physiological parameter monitoring system, clinical

Criticare by Criticare Technologies Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple vital physiological parameter monitoring system, clinical.

Cleared under the same submission

K091050 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Criticare Technologies Corp.

Sources (1)

  • FDA UDI 9551fc2c-7cb3-4121-8015-17b41a633e18 34 fields · synced Jun 6, 2026