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.

General Hospital › TherapeuticPiston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact

Female NRFit Tip Cap

Name: Female NRFit Tip Cap
Brand: Female NRFit Tip Cap

The Female NRFit Tip Cap closes a male NRFit connection on a neuraxial device to prevent fluid loss and contamination. It is intended for NRFit-connected syringes and CADD cassettes used by…

Registry build 21.09.26

The Female NRFit Tip Cap closes a male NRFit connection on a neuraxial device to prevent fluid loss and contamination. It is intended for NRFit-connected syringes and CADD cassettes used by hospital or clinical personnel.

The cap has a female neuraxial lock connection conforming to ISO 80369-6. Its body is made from medical-grade polypropylene with yellow colorant. The closure is intended to remain in place for less than 24 hours during any single application.

Listed Item

Female NRFit Tip Cap for male Neuraxial devices

Sterile Single Use

The cap is supplied sterile following ethylene-oxide sterilization and is intended for one use. Its specified environment is the general hospital, with the connector matched to the corresponding NRFit neuraxial connection.

1manufacturer

1catalogue number

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 Female NRFit Tip Cap
Listed by	Tech Industries. Inc., 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, Repacker / relabeller, Manufacturer, Exporter
510(k)	K201031
Record published	2026-01-23

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
Packaging	Box of 10

Catalogue Numbers

Catalogue numbers for Female NRFit Tip Cap
Catalogue number	Size	Per pack	Status
57-603		10	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BD Syringe NRFit™ Lok	Becton, Dickinson AND Company	5
BD Syringe NRFit™ Slip	Becton, Dickinson AND Company	3
Caina	Jiangsu Caina Medical Co., Ltd.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K201031	2020-12-16

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.