Mark IV Resuscitatorwith single shutter patient va
- Primary DI
- 05707480035663
- Brand
- Mark IV Resuscitatorwith single shutter patient va
- Company
- Ambu A/S
- Model
- 304009000
- Catalog number
- 304009000
- Device description
- Ambu Mark IV for adults with closed reservoir and Silicone face mask sizes 2 and 5 with blue cuff .
- Published
- 2016-12-19
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| BTM | Ventilator, emergency, manual (resuscitator) |
| OEV | Cardiopulmonary resuscitation aid kit |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | Anesthesiology | 2 |
| OEV | Cardiopulmonary Resuscitation Aid Kit | Anesthesiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05707480019502 | Package | GS1 | 6 | In Commercial Distribution |
| 05707480035663 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05707480019502 | 05707480019502 | 5707480019502 |
| 05707480035663 | 05707480035663 | 5707480035663 |
GMDN Terms
| Term | Definition |
|---|
| Pulmonary resuscitator, manual, reusable | A hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a reusable device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Temperature | -18 Degrees Celsius | 50 Degrees Celsius | |
| Storage Environment Temperature | -40 Degrees Celsius | 70 Degrees Celsius | |
| Storage Environment Temperature | -18 Degrees Celsius | 50 Degrees Celsius | |
Sterilization Methods
| Method |
|---|
|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 305682023
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 05707480135363 | SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator | 520611101 | 520611101 | 2017-10-13 |
| 05707480135585 | SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator | 523631011 | 523631011 | 2018-07-09 |
| 05707480135615 | SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator | 530639011 | 530639011 | 2017-10-13 |
| 05707480136018 | SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator | 544216047 | 544216047 | 2018-05-28 |
| 05707480145294 | SPUR® II Adult Resuscitator | 524614000 | 524614000 | 2020-06-24 |
| 05707480145317 | SPUR® II Pediatric Resuscitator | 531616000 | 531616000 | 2020-06-24 |
| 05707480145348 | SPUR® II Adult Resuscitator | 520611074 | 520611074 | 2020-06-24 |
| 05707480145393 | SPUR® II Adult Resuscitator | 520211000BE | 520211000BE | 2021-04-13 |
| 05707480145416 | SPUR® II Adult Resuscitator | 520211000E | 520211000E | 2021-04-13 |
| 05707480145430 | SPUR® II Adult Resuscitator | 520211001E | 520211001E | 2021-04-13 |
| 05707480145454 | SPUR® II Adult Resuscitator | 520211010E | 520211010E | 2021-04-13 |
| 05707480145478 | SPUR® II Adult Resuscitator | 520214000E | 520214000E | 2021-04-13 |
| 05707480145492 | SPUR® II Adult Resuscitator | 520611000E | 520611000E | 2021-04-13 |
| 05707480145515 | SPUR® II Adult Resuscitator | 521611000E | 521611000E | 2021-04-13 |
| 05707480145539 | SPUR® II Adult Resuscitator | 523211000E | 523211000E | 2021-04-13 |
| 05707480145553 | SPUR® II Adult Resuscitator | 523211001E | 523211001E | 2021-04-13 |
| 05707480145577 | SPUR® II Adult Resuscitator | 523611030E | 523611030E | 2021-04-13 |
| 05707480145591 | SPUR® II Adult Resuscitator | 523611031E | 523611031E | 2021-04-13 |
| 05707480027354 | SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator | 523211000 | 523211000 | 2016-12-19 |
| 05707480027361 | SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator | 523211001 | 523211001 | 2016-12-19 |
Other Devices Sharing Product Codes
ambuusa.com