CTM-400
4 catalogue numbers from 3310-01-15, listed by IVY Biomedical Systems, Inc., United States, under Synchronizer, Ecg / Respirator, Radiographic. 1 manufacturer in China is registered for this product code.
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
Record
| Listed by | IVY Biomedical Systems, Inc., United States |
|---|---|
| FDA product code | IXO |
| Device type | Synchronizer, Ecg / Respirator, Radiographic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1970 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-11-10 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Sizes | Weight 1.25 lb; depth 11 in; width 4 in; height 2 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3310-01-15 | Weight 1.25 lb | In distribution |
| 3310-00-15 | Weight 1.25 lb | In distribution |
| 3310-02-15 | Weight 1.25 lb | In distribution |
| 3310-00-01 | Weight 1.25 lb | In distribution |
Same Product Code
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|---|---|---|
| Pneumo Nonmetalic 89″ Latex Free | Lafayette Instrument Co., Inc. | 1 |
| Pediatric Pneumograph – Non-Metallic w/10′ Tubing | Lafayette Instrument Co., Inc. | 1 |
| Pneumograph – Non-Metallic 14ft. Tubing | Lafayette Instrument Co., Inc. | 1 |
| PED Nonmetal Pneumo 10′ Latex Free | Lafayette Instrument Co., Inc. | 1 |
| Nonmetal Pneumo 12′ Luer Latex Free | Lafayette Instrument Co., Inc. | 1 |
| Pneumograph – Non-Metallic 89in. Tubing | Lafayette Instrument Co., Inc. | 1 |
| Pediatric Pneumograph – Non-Metallic w/89″ Tubing | Lafayette Instrument Co., Inc. | 1 |
| Pneumograph – Non-Metallic 98in. Tubing | Lafayette Instrument Co., Inc. | 1 |
| Pneumograph – Non-Metallic 10ft. Tubing | Lafayette Instrument Co., Inc. | 1 |
| Pneumo Nonmetalic 10′ Latex Free | Lafayette Instrument Co., Inc. | 1 |
| Pneumograph – Non-Metallic 12′ w/Connector | Lafayette Instrument Co., Inc. | 1 |
| Pneumograph – Non-Metallic 18′ w/Connector | Lafayette Instrument Co., Inc. | 1 |
Showing 12 of 15. All products under Synchronizer, Ecg / Respirator, Radiographic
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.