Who else makes this device?

Name: 12.5 in (32 cm) Q2 T-extension set w/ 3 Q2 checkvalve T-sites, in-line checkvalv
Brand: 12.5 in (32 cm) Q2 T-extension set w/ 3 Q2 checkvalve T-sites, in-line checkvalv

General Hospital › TherapeuticTubing, Fluid Delivery

12.5 in (32 Cm) Q2 T-Extension Set W/ 3 Q2 Checkvalve T-Sites, In-Line Checkvalv

Catalogue number 95710, listed by Quest Medical, Inc., United States, under Tubing, Fluid Delivery. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (1), Guangdong (1).

Chinese manufacturers registered for FDA product code FPK
Manufacturer	City	Province	Registered as	Device types
Sterigenics Shanghai ETO Ltd.	Shanghai	Shanghai	Contract manufacturer	65
Vincent Medical (Dong Guan) Manufacturing Co., Ltd.	Dong Guan	Guangdong	Contract manufacturer	29

Record

Regulatory record for 12.5 in (32 cm) Q2 T-extension set w/ 3 Q2 checkvalve T-sites, in-line checkvalv
Listed by	Quest Medical, Inc., United States
FDA product code	FPK
Device type	Tubing, Fluid Delivery
Device class	Class 2
Regulation	21 CFR 880.5440
Establishment	Contract manufacturer, Complaint-file establishment, Manufacturer
510(k)	K800825
Record published	2016-07-29
Record revised	2018-07-06 (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
Packaging	Shipper of 50

Catalogue Numbers

Catalogue numbers for 12.5 in (32 cm) Q2 T-extension set w/ 3 Q2 checkvalve T-sites, in-line checkvalv
Catalogue number	Size	Status
95710		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
High Pressure Tubing	Merit Medical Systems, Inc.	68
Vygon	Vygon Corp.	67
Medex	ICU Medical, Inc	41
High Pressure Tubing, Keep™	Merit Medical Systems, Inc.	25
Pressure Monitor Tubing	Merit Medical Systems, Inc.	21
Medrad® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in)	Bayer Medical Care Inc.	16
Merit Medical®	Merit Medical Systems, Inc.	10
Kew Medical	Douglas Medical Products, Inc	8
Merit Medical®	Argon Critical Care Systems Singapore PTE. Ltd.	5
CIV	Emed Technologies Corporation	5
Medrad® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube	Bayer Medical Care Inc.	5
Lifeshield	ICU Medical, Inc	5

Showing 12 of 51. All products under Tubing, Fluid Delivery

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K800825	1980-05-14

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.