Ambu® ACTion™ Fuser Pump 418104650C
GUDID 05707480155958
Action Fuser, 650 mL, 5-15 mL/hr Reg, 140 mm Cath, 6" Intro
Ambu A/S
Mechanical infusion pump administration set| Primary Device ID | 05707480155958 |
| NIH Device Record Key | d189d2f3-a107-4882-8fc3-c0a6192ff22a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ambu® ACTion™ Fuser Pump |
| Version Model Number | 418104650C |
| Catalog Number | 418104650C |
| Company DUNS | 305682023 |
| Company Name | Ambu A/S |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
| Total Volume | 650 Milliliter |
Operating and Storage Conditions
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05707480155958 [Package] Contains: 05707480155965 Package: [5 Units] In Commercial Distribution |
| GS1 | 05707480155965 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061409
FDA Product Code
| MEB | Pump, infusion, elastomeric |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-11 |
| Device Publish Date | 2022-02-03 |
On-Brand Devices [Ambu® ACTion™ Fuser Pump]
| 05707480156146 | Action Fuser, 400 mL, 1-6 mL/hr Reg, Dual Cath, Splitter |
| 05707480156115 | Action Fuser, 200 mL, 1-6 mL/hr Reg, 140 mm Cath, 6" intro |
| 05707480156092 | Action Fuser, 650 mL, 5-15 mL/hr Reg, 140 mm Cath, 6" Intro |
| 05707480156078 | Action Fuser, 200 mL, 1-6 mL/hr Reg, Dual Cath, Splitter |
| 05707480156054 | Action Fuser, 400 mL, 1-6 mL/hr Reg, 140 mm Cath, 6" Intro |
| 05707480156030 | ACTion Fuser,400 mL,1-6 ml, Dual 190mm Cath,9"Intro, Spliter |
| 05707480156016 | ACTion Fuser 400 ml, 5-15 ml/hr, Dual Cath 190 mm, Splitter |
| 05707480155996 | Action Fuser, 400 mL, 1-6 mL/hr Reg, Dual Cath, Splitter |
| 05707480155972 | Action Fuser, 200 mL, 1-6 mL/hr Reg, 140 mm Cath, 6" intro |
| 05707480155958 | Action Fuser, 650 mL, 5-15 mL/hr Reg, 140 mm Cath, 6" Intro |
| 05707480155934 | Action Fuser, 200 mL, 1-6 mL/hr Reg, Dual Cath, Splitter |
| 05707480155910 | Action Fuser, 400 mL, 1-6 mL/hr Reg, 140 mm Cath, 6" Intro |
Trademark Results [Ambu]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMBU 98192535 not registered Live/Pending |
AMBU A/S 2023-09-22 |
 AMBU 90002202 not registered Live/Pending |
AMBU 2020-06-15 |
 AMBU 79051291 3554442 Live/Registered |
AMBU A/S 2008-02-15 |
 AMBU 74156351 1686178 Live/Registered |
AMBU A/S 1991-04-12 |
 AMBU 73438330 1330624 Dead/Cancelled |
Testa-Laboratorium A/S 1983-08-08 |
 AMBU 73023700 1040868 Dead/Expired |
TESTA-LABORATORIUM A/S 1974-06-10 |
 AMBU 72127671 0740102 Dead/Cancelled |
Testa Laboratorium A/S 1961-09-11 |
 AMBU 72055090 0705020 Dead/Cancelled |
TESTA LABORATORIUM A/S 1958-07-10 |
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