Underpad Quilted Ibex
Underpad Quilted Canadian Ibex 33X36 Kaum RM (98 7135) USE: 59750110
89manufacturers in China registered for this device type
68catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (23), Jiangsu (20), Guangdong (12). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Jiangsu Keling Medical Appliances Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 23 |
| Jiangyin Huashi Medical Equipment Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 21 |
| Dongguan China Effort Healthcare Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Changzhou Care-DE Sanitary Material Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Hubei Haixin Protective Products Group Co., Ltd. | Songzi | Hubei | Contract manufacturer | 10 |
| Shenzhen Lantise Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Changzhou Hongtai Paper Film Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Suzhou Baili Medical Supplies Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Jiangsu Hanfang Textile Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 8 |
| Jinhua Yueer ART Craft Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 6 |
| Haining Yikang Textile Co., Ltd. | Haining | Zhejiang | Contract manufacturer | 5 |
Showing 12 of 89. All 89 manufacturers in China registered for Cover, Mattress (Medical Purposes)
Record
| Listed by | Standard Textile Co., Inc., United States |
|---|---|
| FDA product code | FMW |
| Device type | Cover, Mattress (Medical Purposes) |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6190 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-29 |
| Record revised | 2023-07-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2024-12-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 59748100 | 24 | In distribution | |
| 59748E07 | 24 | In distribution | |
| 59731100 | 24 | In distribution | |
| 597T1900 | 24 | In distribution | |
| 5974834R | 24 | In distribution | |
| 59748E87 | 24 | In distribution | |
| 59750500 | 24 | In distribution | |
| 59748E74 | 24 | In distribution | |
| 59710110 | 24 | In distribution | |
| 597481G3 | 24 | Withdrawn | |
| 59750110 | 24 | Withdrawn | |
| 59750CA9 | 24 | Withdrawn | |
| 5971011C | 24 | Withdrawn | |
| 59748DT7 | 24 | Withdrawn | |
| 597B8500 | 24 | Withdrawn | |
| 59733800 | 24 | Withdrawn | |
| 597R8200 | 24 | Withdrawn | |
| 597E7410 | 24 | Withdrawn | |
| 5974DE10 | 24 | Withdrawn | |
| 59748CC3 | 24 | Withdrawn | |
| 597E7110 | 24 | Withdrawn | |
| 597E7210 | 24 | Withdrawn | |
| 597M3400 | 24 | Withdrawn | |
| 59748068 | 24 | Withdrawn | |
| 5974813C | 24 | Withdrawn | |
| 59755K77 | 24 | Withdrawn | |
| 59748EK1 | 24 | Withdrawn | |
| 5975057W | 24 | Withdrawn | |
| 5974833P | 24 | Withdrawn | |
| 59785350 | 24 | Withdrawn | |
| 5974DE11 | 24 | Withdrawn | |
| 59772930 | 24 | Withdrawn | |
| 5974843Y | 24 | Withdrawn | |
| 597E8010 | 24 | Withdrawn | |
| 59761900 | 24 | Withdrawn | |
| 597G9710 | 24 | Withdrawn | |
| 59772881 | 24 | Withdrawn | |
| 597T5800 | 24 | Withdrawn | |
| 59748EJ7 | 24 | Withdrawn | |
| 5975035B | 24 | Withdrawn | |
| 59742600 | 24 | Withdrawn | |
| 597E8910 | 24 | Withdrawn | |
| 59748CJ3 | 24 | Withdrawn | |
| 597481K0 | 24 | Withdrawn | |
| 59748DY1 | 24 | Withdrawn | |
| 597M6000 | 24 | Withdrawn | |
| 597P1010 | 24 | Withdrawn | |
| 597481G1 | 24 | Withdrawn | |
| 59715010 | 24 | Withdrawn | |
| 597Y1110 | 24 | Withdrawn | |
| 597505AM | 24 | Withdrawn | |
| 59748EB2 | 24 | Withdrawn | |
| 597E8410 | 24 | Withdrawn | |
| 597Q2900 | 24 | Withdrawn | |
| 597E7000 | 24 | Withdrawn | |
| 597481M8 | 24 | Withdrawn | |
| 59766330 | 24 | Withdrawn | |
| 59748E76 | 24 | Withdrawn | |
| 59734100 | 24 | Withdrawn | |
| 597H0100 | 24 | Withdrawn | |
| 59748E36 | 24 | Withdrawn | |
| 59748CE4 | 24 | Withdrawn | |
| 597X2710 | 24 | Withdrawn | |
| 59748CH1 | 48 | Withdrawn | |
| 59748ED8 | 24 | Withdrawn | |
| 59748DV1 | 24 | Withdrawn | |
| 597E7010 | 24 | Withdrawn | |
| 59748EE5 | 24 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| C-Matt | Casco Manufacturing Solutions, Inc. | 171 |
| Cmatt | Casco Manufacturing Solutions, Inc. | 43 |
| Casco | Casco Manufacturing Solutions, Inc. | 35 |
| Underpad Quilted | Standard Textile Co., Inc. | 29 |
| SelectAir | Moxi Enterprises, LLC | 28 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 20 |
| Drivemedical | Drive DeVilbiss Healthcare | 19 |
| Underpad Integrity | Standard Textile Co., Inc. | 18 |
| CT Gantry Cover | Pearl Inc. | 16 |
| ProtectYou2 | Moxi Enterprises, LLC | 13 |
| Excel Plus Comply Quilted PAD | Standard Textile Co., Inc. | 12 |
| Sures | Vive Health LLC | 12 |
Showing 12 of 244. All products under Cover, Mattress (Medical Purposes)
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.