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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 2101 East St. Elmo Rd., Austin, TX, 78744
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000117854
- DUNS Number
- 788403103
Catalogue (49)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AffloVest | 8300XL | FDA UDI | Class II | Unknown |
| IBC Aortic Punch, Medium, 4.8mm | APM48 | FDA UDI | Class I | Unknown |
| FloPump | FloPump/FloProbe Kit (Non-Sterile) | FDA UDI | Class II | Unknown |
| AffloVest | 8200 | FDA UDI | Class II | Unknown |
| Stableline Tubing Organizer (Sterile) | 5000S | FDA UDI | Class I | Unknown |
| IBC Aortic Punch, Medium, 4.4mm | APM44 | FDA UDI | Class I | Unknown |
| IBC Aortic Punch, Medium, 5.2mm | APM52 | FDA UDI | Class I | Unknown |
| IBC Aortic Punch, Medium, 3.6mm | APM36 | FDA UDI | Class I | Unknown |
| FloPump | 1/4" FloPump (Sterile) | FDA UDI | Class II | Unknown |
| IBC Aortic Punch, Long, 4.8mm | APL48 | FDA UDI | Class I | Unknown |
| IBC Aortic Punch, Medium, 5.6mm | APM56 | FDA UDI | Class I | Unknown |
| FloPump | 6500N | FDA UDI | Class II | Unknown |
| IBC Aortic Punch, Medium, 4.0mm | APM40 | FDA UDI | Class I | Unknown |
| IBC Suction Wand (Sterile) | 1990S | FDA UDI | Class II | Unknown |
| FloPump | 6400N | FDA UDI | Class II | Unknown |
| IBC Aortic Punch, Long, 4.0mm | APL40 | FDA UDI | Class I | Unknown |
| AffloVest | 8100XS | FDA UDI | Class II | Unknown |
| FloProbe 1/4’’ x 1/4’’ (Sterile) | 3090S | FDA UDI | Class II | Unknown |
| FloPump | 6400S | FDA UDI | Class II | Unknown |
| FloProbe 3/8" x 3/8” (Sterile) | 3080S | FDA UDI | Class II | Unknown |
| IBC Mini Sucker (Sterile) | 1980S | FDA UDI | Class II | Unknown |
| IBC Aortic Punch, Long, 2.8mm | APL28 | FDA UDI | Class I | Unknown |
| FloProbe 1/4’’ x 1/4" (Non Sterile) | 3090N | FDA UDI | Class II | Unknown |
| IBC Suction Wand (Non Sterile) | 1990N | FDA UDI | Class II | Unknown |
| FloPump | FloPump/FloProbe Kit (Sterile) | FDA UDI | Class II | Unknown |
| FloPump | FloPump (Non-Sterile) | FDA UDI | Class II | Unknown |
| Stableline Tubing Organizer (Non Sterile) | 5000N | FDA UDI | Class I | Unknown |
| IBC Aortic Punch, Medium, 2.8mm | APM28 | FDA UDI | Class I | Unknown |
| AffloVest | 8100XXS | FDA UDI | Class II | Unknown |
| FloProbe 3/8’’ x 3/8” (Non Sterile) | 3080N | FDA UDI | Class II | Unknown |
| Mpv | MV5000 | FDA UDI | Class I | Active |
| AffloVest | 8300 | FDA UDI | Class II | Unknown |
| IBC Aortic Punch, Long, 6.0mm | APL60 | FDA UDI | Class I | Unknown |
| FloPump | 6500S | FDA UDI | Class II | Unknown |
| IBC Aortic Punch, Medium, 6.0mm | APM60 | FDA UDI | Class I | Unknown |
| AffloVest | 8300XXL | FDA UDI | Class II | Unknown |
| IBC Aortic Punch, Long, 3.6mm | APL36 | FDA UDI | Class I | Unknown |
| IBC Aortic Punch, Long, 5.6mm | APL56 | FDA UDI | Class I | Unknown |
| IBC Aortic Punch, Long, 4.4mm | APL44 | FDA UDI | Class I | Unknown |
| FloPump | 1/4" FloPump/FloProbe Kit (Sterile) | FDA UDI | Class II | Unknown |
| IBC Tubing Organizer (Non Sterile) | 5020N | FDA UDI | Class I | Unknown |
| IBC Aortic Punch, Long, 5.2mm | APL52 | FDA UDI | Class I | Unknown |
| IBC Mini Sucker (Non Sterile) | 1980N | FDA UDI | Class II | Unknown |
| AffloVest | 8100 | FDA UDI | Class II | Unknown |
| Mpv | MV5001 | FDA UDI | Class I | Active |
| AffloShield | 8600 | FDA UDI | Class I | Unknown |
| FloPump | FloPump (Sterile) | FDA UDI | Class II | Unknown |
| FloPump | 1/4" FloPump (Non-Sterile) | FDA UDI | Class II | Unknown |
| IBC Tubing Organizer (Sterile) | 5020S | FDA UDI | Class I | Unknown |
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