Who else makes this device?

Name: Infinity Pole Clamp
Brand: Infinity Pole Clamp

Infinity Pole Clamp · Pump, Infusion, Enteral → General Hospital

5manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

4recalls on this code

Who Else Makes It

Concentrated in Zhejiang (2), Jiangsu (1), Shanghai (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 LZH
Manufacturer	City	Province	Registered as	Device types
Primecare Medical (Huzhou) Co., Ltd.	Hu Zhou	Zhejiang	Contract manufacturer	9
Dongguan Motormillions Industries Co., Ltd.	Guangdong	Guangdong	Contract manufacturer	1
Amsino Medical (Kunshan) Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	53
Hangzhou Primecare Medical Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Cardinal Medical Equipment Consulting (Shanghai)Co., Ltd.	Shanghai	Shanghai	Exporter	9

Record

Regulatory record for Infinity Pole Clamp
Listed by	Zevex, Inc., United States
FDA product code	LZH
Device type	Pump, Infusion, Enteral
Device class	Class 2
Regulation	21 CFR 880.5725
Establishment	Contract manufacturer, Specification developer, Manufacturer, Exporter
Record published	2021-08-18

Specifications

Specifications
MRI safety	MR Unsafe

Catalogue Numbers

Catalogue numbers for Infinity Pole Clamp
Catalogue number	Size	Status
Infinity Pole Clamp		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Kangaroo	Cardinal Health	61
Kangaroo	Cardinal Health 200, LLC	54
Infinity	Zevex, Inc.	24
Infinity Enteral Feeding Pump	Zevex, Inc.	14
Infinity Orange Enteral Feeding Pump	Zevex, Inc.	8
Perfusor®	B. Braun Medical Inc.	4
Medline	Medline Industries, Inc.	3
Sentinel®	Alcor Scientific LLC	3
Novum IQ	Baxter Healthcare Corporation	2
Infinity Small Volume Feeding Bag and Set	Zevex, Inc.	2
Moog Medical Infinity Pole Clamp	Zevex, Inc.	2
Vesco Medical 500mL Bag (PVC) Q Pump Feed Set with ENFit	Vesco Medical LLC	1

Showing 12 of 26. All products under Pump, Infusion, Enteral

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K131154	2014-02-12
K031199	2003-07-09
K954735	1996-04-15

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2012-11-08	Class II	Component design/selection	MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient	8,736	2014-01-30
2012-10-12	Class II	Nonconforming Material/Component	The firm is adding an addendum to the operator’s manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.	92,488 units	2014-04-10
2008-12-18	Not classified	Software design (manufacturing process)	Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.	32,545	2011-10-27
2008-12-18	Not classified	Software design (manufacturing process)	Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.	318	2011-10-27

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.

Infinity Pole Clamp