Ambu® ACTion™ Fuser Pump 418108200M
GUDID 05707480156078
Action Fuser, 200 mL, 1-6 mL/hr Reg, Dual Cath, Splitter
Ambu A/S
Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set| Primary Device ID | 05707480156078 |
| NIH Device Record Key | 7b358edc-3a43-4539-8a7c-f275748684dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ambu® ACTion™ Fuser Pump |
| Version Model Number | 418108200M |
| Catalog Number | 418108200M |
| 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 | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 Milliliter |
| Total Volume | 200 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 | 05707480156078 [Package] Contains: 05707480156085 Package: [5 Units] In Commercial Distribution |
| GS1 | 05707480156085 [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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