What is FDA product code QEH?

A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or intracerebroventricular administration routes. The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.

BD Syringe NRFit™ Lok · Piston Syringe with Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact → General Hospital

Name: BD Syringe NRFit™ Lok
Brand: BD Syringe NRFit™ Lok

1manufacturer

5catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code QEH
Manufacturer	City	Province	Registered as	Device types
Jiangsu Caina Medical Co., Ltd.	Jiangyin	Jiangsu	Contract manufacturer	20

Record

Regulatory record for BD Syringe NRFit™ Lok
Listed by	Becton, Dickinson AND Company, United States
FDA product code	QEH
Device type	Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
Device class	Class 2
Regulation	21 CFR 880.5860
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer
Record published	2022-03-21
Record revised	2025-08-01 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Special storage condition: Keep away from sunlight; Special storage condition: Fragile, handle with care; Special storage condition: Keep dry; Special storage condition: Room Temperature
Packaging	Case of 4, shelfpack of 200, shelfpack of 125, shelfpack of 48, case of 2, shelfpack of 40
Sizes	Total volume 3 to 50 ml

Catalogue Numbers

Catalogue numbers for BD Syringe NRFit™ Lok
Catalogue number	Size	Status
400173	Total Volume 5 ml	In distribution
400050	Total Volume 3 ml	In distribution
400182	Total Volume 20 ml	In distribution
400174	Total Volume 10 ml	In distribution
400183	Total Volume 50 ml	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BD Syringe NRFit™ Slip	Becton, Dickinson AND Company	3
Caina	Jiangsu Caina Medical Co., Ltd.	1
Female NRFit Tip Cap	Tech Industries. Inc.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K192538	2020-09-04

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.

BD Syringe NRFit™ Lok