ambIT
Pain Control System - Basic with Filter Male Luer Cassette + MediBag
3manufacturers in China registered for this device type
34catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Anhui (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Anhui Medpurest Medical Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 46 |
| Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd. | Jintan | Jiangsu | Contract manufacturer | 10 |
Record
| Listed by | Summit Medical Products, Inc., United States |
|---|---|
| FDA product code | OFQ |
| Device type | Anesthesia Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| Premarket notification | Exempt |
| Record published | 2020-05-06 |
| Record revised | 2019-12-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5, pack of 20, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 220575 | In distribution | |
| 220477 | In distribution | |
| 220405 | In distribution | |
| 220569 | In distribution | |
| 220561 | In distribution | |
| 220574 | In distribution | |
| 220528 | In distribution | |
| 220449 | In distribution | |
| 220342 | In distribution | |
| 220537 | In distribution | |
| 220463 | In distribution | |
| 220562 | In distribution | |
| 220473 | In distribution | |
| 220532 | In distribution | |
| 220470 | In distribution | |
| 220472 | In distribution | |
| 220316 | In distribution | |
| 220493 | In distribution | |
| 220560 | In distribution | |
| 220541 | In distribution | |
| 220539 | In distribution | |
| 220573 | In distribution | |
| 220466 | In distribution | |
| 220462 | In distribution | |
| 220563 | In distribution | |
| 220469 | In distribution | |
| 220471 | In distribution | |
| 220266mil | In distribution | |
| 220343 | In distribution | |
| 220542 | In distribution | |
| 220451 | In distribution | |
| 220404 | In distribution | |
| 220344 | In distribution | |
| 220568 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 2,332 |
| Medline Industries, Inc. | Medline Industries, Inc. | 54 |
| ACS | American Contract Systems, Inc. | 21 |
| ambIT* | Avanos Medical, Inc. | 19 |
| Stradis Healthcare | Stradis Healthcare | 11 |
| Stradis | Stradis Healthcare | 9 |
| Henry Schein | Henry Schein, Inc. | 6 |
| Invenio | GRI-Alleset, Inc. | 2 |
| ambIT* Cassette – Filter, Spike | Avanos Medical, Inc. | 2 |
| ambIT* Cassette – Filter, Spike with Yellow Striped Tubing | Avanos Medical, Inc. | 2 |
| Continuous Regional Anesthesia Kit | Custom Interventional Pain Management | 2 |
| ambIT* Military PCA Pump | Avanos Medical, Inc. | 1 |
Showing 12 of 22. All products under Anesthesia Kit
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.