← Back to catalogue

Hopkins

FDA UDI

Class II (US FDA UDI)

by Marketlab Inc.

Identity

Trade Name
Hopkins FDA UDI
Generic Name
Pulse oximeter FDA UDI
Device Name
Pediatric Reusable Soft Probe FDA UDI
Model / Reference
138040 FDA UDI
Description
Pediatric Reusable Soft Probe FDA UDI

Identifiers

Primary DI / UDI-DI
00817643023958 FDA UDI
510(k) Number
K172792 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Pulse oximeter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 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

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulse oximeter

Hopkins by Marketlab Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter.

Cleared under the same submission

K172792 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Marketlab Inc.

Sources (1)

  • FDA UDI ed360700-ee81-4e9f-9a02-699ca1b0392b 34 fields · synced Jun 8, 2026