FDA device listing
BEDDING,CleanOp: bedding and cleaning supplies,ComfortGlide Drypad,DISPOSABLE BEDDING,Extrasorb,FitRight,FitRight…
FDA device listing 1229232440 · Medline Industries, LP
Key facts
| Proprietary names | BEDDING,CleanOp: bedding and cleaning supplies,ComfortGlide Drypad,DISPOSABLE BEDDING,Extrasorb,FitRight,FitRight Extended Use Underpad,MEDICAL GENERAL HOSPITAL,Medline Disposable Underpads,Microtek Disposable Baby Blanket,MICROTEK DISPOSABLE BEDDING,OREX MEDICAL BEDDING,Protection Plus Disposable Underpads,Ultrasorb,Ultrasorb, Extrasorb, Therasorb, Drypad, Underpads |
|---|---|
| Owner/operator | Medline Industries, LP |
| Owner/operator number | 1417592 |
| Product codes | KME |
| Device names | KME - Bedding, Disposable, Medical |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6060 |
| Review panels | General Hospital |
| Registered establishments | Medline Canada, MEDLINE INDUSTRIES, LP - Laredo, Medline Industries, LP - Lithia Springs, Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP - Northfield, MEDLINE INDUSTRIES, LP (Northpoint Services), Microtek Dominicana, S.A.S., MICROTEK DOMINICANA, S.A.S., Microtek Medical B.V., Microtek Medical LLC |
| Establishment registrations | 1417592, 1422634, 8043817, 1000110779, 3005425620, 3005595283, 3006116468, 3007289408, 3012811961, 3013401749, 3014342658, 3015173212, 3021970868 |
| FEI numbers | 1417592, 1000110779, 1000514656, 3003094575, 3005425620, 3005595283, 3006116468, 3007289408, 3012811961, 3013401749, 3014342658, 3015173212, 3021970868 |
| Establishment operations | Contract Sterilizer, Manufacturer, Foreign Exporter, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 10–99 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database