Computer, Oxygen-Uptake

D-Lite+ Sensor, Disposable, Adult

Registry build 21.09.26
3manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BZL
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Mehow Innovative Ltd Shenzhen Guangdong Contract manufacturer 2
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57

Record

Regulatory record for Computer, Oxygen-Uptake
Listed by GE Healthcare Finland OY, Finland
FDA product code BZL
Device type Computer, Oxygen-Uptake
Device class Class 2
Regulation 21 CFR 868.1730
Establishment Specification developer, Repacker / relabeller, Manufacturer
Record published 2016-06-16
Record revised 2025-04-29 (version 11)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Packaging Box of 50

Catalogue Numbers

Catalogue numbers for Computer, Oxygen-Uptake
Catalogue number Size Status
D-lite sensor, reusable, Adult In distribution
D-lite sensor, disposable, Adult In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MGC Diagnostics Medical Graphics Corp. 43
Cosmed C O S M E D SRL 4
Metaphor Flow Sensor TreyMed, Inc. 3
MCG Diagnostics Medical Graphics Corp. 1
Vista Mini-CPX Silver Edition Vacumed 1
Maxii AEI Technologies Inc. 1
MGC Diganostics Medical Graphics Corp. 1
MAXIIa AEI Technologies Inc. 1
Vista-MX Metabolic Measurement System Vacumed 1
MGC Diagnsotics Medical Graphics Corp. 1
MediPines Gas Exchange Monitor Starter Kit Medipines Corporation 1
Microlife Microlife USA, Inc. 1

Showing 12 of 22. All products under Computer, Oxygen-Uptake

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer