Henry Schein
Pack Surgical Pain F/ Advanced Ambulatory Surgery Center
3manufacturers in China registered for this device type
6catalogue 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 | Henry Schein, 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 | 2024-01-29 |
| Record revised | 2022-06-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5703581 | 32 | In distribution | |
| 5703236 | 25 | In distribution | |
| 5703210 | 5 | In distribution | |
| 5703582 | 32 | In distribution | |
| 5703202 | 5 | In distribution | |
| 5703061 | 20 | 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 |
| ambIT | Summit Medical Products, Inc. | 34 |
| ACS | American Contract Systems, Inc. | 21 |
| ambIT* | Avanos Medical, Inc. | 19 |
| Stradis Healthcare | Stradis Healthcare | 11 |
| Stradis | Stradis Healthcare | 9 |
| 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.