FDA device listing
EPI KIT,IV Start Kit,Tourniquet
FDA device listing 1610530993 · HemaSource, Inc.
Key facts
| Proprietary names | EPI KIT,IV Start Kit,Tourniquet |
|---|---|
| Owner/operator | HemaSource, Inc. |
| Owner/operator number | 10060360 |
| Product codes | NAB |
| Device names | NAB - Gauze / Sponge,Nonresorbable For External Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4014 |
| Review panels | General & Plastic Surgery |
| Registered establishments | HEMASOURCE, HemaSource, Inc., Source Products, Ltd. |
| Establishment registrations | 1724809, 3010611994, 3016540041 |
| FEI numbers | 3002996286, 3010611994, 3016540041 |
| Establishment operations | Contract Manufacturer, Repackager/Relabeler, Manufacturer |
| 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