Spray / Pump
Catalogue number 0651, 0681, 0671, 0695, 0661, 0641, 0631, listed by Jhk, Inc., under Sprays, Synthetic, Smear. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (1), Zhejiang (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Ningbo Cooskin Stationery Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 18 |
| Jiaoyue Pharmaceutical (Huizhou) Co., Ltd. | Huizhou | Guangdong | Manufacturer | 9 |
Record
| Listed by | Jhk, Inc. |
|---|---|
| FDA product code | IFI |
| Device type | Sprays, Synthetic, Smear |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Premarket notification | Exempt |
| Record published | 2023-07-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 0651, 0681, 0671, 0695, 0661, 0641, 0631 | 24 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dynamic Freeze | Ecotec Manufacturing | 1 |
| Max Pro Medical Freeze Spray | Ecotec Manufacturing | 1 |
| Cold AS ICE | Ecotec Manufacturing | 1 |
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.