Puritan Bennett

Neonatal Flow and CO2 Sensor Disposable;For 980 Series Ventilator

Registry build 21.09.26
1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code BXP
Manufacturer City Province Registered as Device types
Unimed Medical Supplies Inc Shenzhen Guangdong Contract manufacturer 15

Record

Regulatory record for Puritan Bennett
Listed by Covidien LP, United States
FDA product code BXP
Device type Transducer, Gas Flow
Device class Class 1
Regulation 21 CFR 868.2885
Premarket notification Exempt
Record published 2023-02-03
Record revised 2025-06-24 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date
Storage Special storage condition: Keep dry; Storage environment temperature -40 to 158 °F
Packaging Case of 10

Catalogue Numbers

Catalogue numbers for Puritan Bennett
Catalogue number Size Status
10047078 In distribution
10005002 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Flow Sensor Respironics Novametrix, LLC 10
Create Biotech Create Biotech Co., Ltd. 8
Infinity ID Flow Sensor Drägerwerk AG & Co. KGaA 1
Flow sensor Honeywell Healthcare Solutions GmbH 1
Respiratory Mech mod,w/accssry Shenzhen Mindray BIO-Medical Electronics Co., Ltd. 1
Respiratory Mechanics Flow Sensor → Adult/Pediatric Draeger Medical Systems, Inc. 1
Spirolog Flow Sensor Drägerwerk AG & Co. KGaA 1
SpiroLife Drägerwerk AG & Co. KGaA 1
Spiro-SP TrueFlow Sensor NDD Medizintechnik AG 1

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