FDA device listing
Vakly Commode Liner With Absorbent Pad,Vakly Disposable Underpads,Vakly Drape Sheet,Vakly Exam Table Paper,Vakly…
FDA device listing 1306526813 · Avaline Medical NJ Limited Liability Company
Key facts
| Proprietary names | Vakly Commode Liner With Absorbent Pad,Vakly Disposable Underpads,Vakly Drape Sheet,Vakly Exam Table Paper,Vakly Stretcher Sheets,Vakly TIssue/Poly Pillowcases,Vakly Tray Sleeve |
|---|---|
| Owner/operator | Avaline Medical NJ Limited Liability Company |
| Owner/operator number | 10077314 |
| 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 | Avaline Medical Limited Liability Company |
| Establishment registrations | 3017231740 |
| FEI numbers | 3017231740 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 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