Infinity
Enteralite Infinity Super Mini Backpack, Green/Gray
5manufacturers in China registered for this device type
24catalogue numbers in this listing
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.
| 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
| 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 | 2018-08-03 |
| Record revised | 2026-05-18 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Packaging | Pack of 3, pack of 5 |
| Distribution end date | 2021-03-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Infinity Mini Backpack, Green/Gray | In distribution | |
| Infinity Super Mini Backpack, Green/Gray | In distribution | |
| Infinity Waist Pack, Black | In distribution | |
| PCK4001 | In distribution | |
| Infinity Adult Pack, Black | In distribution | |
| PCK1002 | In distribution | |
| Infinity Mini Backpack, Black | In distribution | |
| Infinity Mini Backpack, Red | In distribution | |
| PCK3001 | In distribution | |
| A/C Adapter Charger | In distribution | |
| PCK2002 | In distribution | |
| PCK1001 | In distribution | |
| PCK1003 | In distribution | |
| Infinity Super Mini Backpack, Black | In distribution | |
| Infinity A/C Adapter | In distribution | |
| PCK2001 | In distribution | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kangaroo | Cardinal Health | 61 |
| Kangaroo | Cardinal Health 200, LLC | 54 |
| 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 |
| MedSystem III | BD Switzerland Sàrl | 1 |
Showing 12 of 26. All products under Pump, Infusion, Enteral
510(K) Clearances
| 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.
| 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.