Medline Industries, Inc.
Anesthesia Circuit Peds 120-LF
3manufacturers in China registered for this device type
54catalogue 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 | Medline Industries, 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 | 2016-11-07 |
| Record revised | 2022-06-17 (version 6) |
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 |
| Packaging | Case of 20, pack of 20, case of 11, case of 30, case of 8, case of 22 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJAA10514A | In distribution | |
| DYNJ38689 | In distribution | |
| DYNJAA10557 | In distribution | |
| DYNDM1095 | In distribution | |
| DYNJAAF6665 | In distribution | |
| PAIN1054 | In distribution | |
| DYNJAP9853D | In distribution | |
| DYNJAA0298A | In distribution | |
| DYNJAP9929 | In distribution | |
| DYNJAP4748A | In distribution | |
| DYNJ28327B | In distribution | |
| DYNJAP6182 | In distribution | |
| DYNJAA10546 | In distribution | |
| DYNJAA10555 | In distribution | |
| DYNJAA4830 | In distribution | |
| DYNJ10550 | In distribution | |
| DYNJAA10545 | In distribution | |
| DYNJ59653B | In distribution | |
| DYNJ61839B | In distribution | |
| DYNJAP6181 | In distribution | |
| DYNJ34129C | In distribution | |
| DYNJAA10546A | In distribution | |
| DYNJAA10558 | In distribution | |
| DYNJAA10554 | In distribution | |
| DYNJ49869A | In distribution | |
| DYNJAA10044B | In distribution | |
| DYNJ54607A | In distribution | |
| DYNJAA10523 | In distribution | |
| DYNJAA10338C | In distribution | |
| DYNJ39498A | In distribution | |
| DYNJ49739A | In distribution | |
| DYNJAA10044C | In distribution | |
| DYNJAP9851D | In distribution | |
| DYNJ57590 | In distribution | |
| DYNJAA6612 | In distribution | |
| DYNJ49739 | In distribution | |
| DYNJAA10559 | In distribution | |
| DYNJAAF6586A | In distribution | |
| DYNJ54415 | In distribution | |
| DYNJ34129B | In distribution | |
| DYNJ55124 | In distribution | |
| DYNJAAF6656 | In distribution | |
| DYNJAAF6525 | In distribution | |
| DYNJAA10543 | In distribution | |
| DYNJ46489C | In distribution | |
| DYNJAA0075C | In distribution | |
| DYNJ54607 | In distribution | |
| DYNJ37771 | In distribution | |
| DYNJAA10550 | In distribution | |
| DYNJAA10549 | In distribution | |
| DYNJAP9837 | In distribution | |
| DYNJAAF6504A | In distribution | |
| DYNJAA10044A | In distribution | |
| DYNJAA10474A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 2,332 |
| 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 |
| 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2025-10-10 | Class I | Nonconforming Material/Component | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120″ expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may resu | 96,406 total units |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 8 cases (200 units) |
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.