Identity
- Trade Name
- FAST1 STERNAL IO DEV STERILE EUDAMEDARROW FDA UDI
- Generic Name
- Intraosseous infusion kit FDA UDI
- Device Name
- FAST 1 Sternal Intraosseous Device EUDAMEDFAST1 STERNAL IO DEV STERILE FDA UDI
- Model / Reference
- 01-0042RTR EUDAMEDIPN922674 FDA UDI
- Description
- FAST1 STERNAL IO DEV STERILE FDA UDI
Identifiers
- Catalog Number
- 01-0042RTR FDA UDI
- Primary DI / UDI-DI
- 60801902203214 EUDAMEDFDA UDI
- Basic UDI-DI
- 08019020000000000000284L2 EUDAMED
- 510(k) Number
- K180588 FDA UDI
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
- GMDN Term
- Intraosseous infusion kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intraosseous infusion kit
Fast1 Sternal Io Dev Sterile by Teleflex Medical — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08019020000000000000284L2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Medical
- EUDAMED SRN
- IE-MF-000015868
Sources (2)
- EUDAMED ae592ea2-3148-42e5-8b64-16beeb269ff8 61 fields · synced Jun 19, 2026
- FDA UDI 8f060202-eb91-43c5-b161-fc847a9a36aa 36 fields · synced May 30, 2026