Identity
- Trade Name
- SmartInfuser Set, 1-6 ml/hr FDA UDI
- Generic Name
- Elastomeric infusion pump kit FDA UDI
- Device Name
- Regulating Set 1-6, stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY) FDA UDI
- Model / Reference
- 418000531 FDA UDI
- Description
- Regulating Set 1-6, stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05707480110674 FDA UDI
- 510(k) Number
- K061409 FDA UDI
- FDA Product Code
- MEB FDA UDI
- GMDN Term
- Elastomeric infusion pump kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Elastomeric infusion pump kit
SmartInfuser Set, 1-6 ml/hr by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Elastomeric infusion pump kit.
- LMA — TELEFLEX INCORPORATED · Class II
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- Halyard — Avanos Medical, Inc. · Class II
- AVANOS* — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- LMA — TELEFLEX INCORPORATED · Class II
- Halyard — Avanos Medical, Inc. · Class II
- LMA — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K061409 also covers:
- 4" introducerStand alone, complementary accessory (to be used with ACT — Ambu A/S
- 6" introducerStand alone, complementary accessory (to be used with ACT — Ambu A/S
- 9" Peel-A-Way Introducer — Ambu A/S
- ACTion Fuser Pump, 200ml, 1-6 ml/hr, (no catheter) — Ambu A/S
- ACTion Fuser Pump, 200ml, 1-6 ml/hr140mm caut-to-size catheter — Ambu A/S
- ACTion Fuser Pump, 200ml, 1-6 ml/hr140mm caut-to-size catheter, 4" int — Ambu A/S
- ACTion Fuser Pump, 200ml, 1-6 ml/hr190mm caut-to-size catheter — Ambu A/S
- ACTion Fuser Pump, 200ml, 1-6 ml/hrDual 140mm caut-to-size catheter — Ambu A/S
- ACTion Fuser Pump, 200ml, 1-6 ml/hrDual 190mm caut-to-size catheter (t — Ambu A/S
- ACTion Fuser Pump, 200ml, 1-6 ml/hrMultiBolus, 140mm caut-to-size cath — Ambu A/S
- ACTion Fuser Pump, 200ml, 5-15 ml/hr, 140mm caut-to-size catheter — Ambu A/S
- ACTion Fuser Pump, 200ml, 5-15 ml/hrMultiBolus, 140mm caut-to-size cat — Ambu A/S
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ambu A/S
Sources (1)
- FDA UDI 7605f99e-511c-45c1-b68f-419f5fbfb0c8 36 fields · synced May 31, 2026