Ambu® SPUR® II Adult Resuscitator
- Primary DI
- 05707480149162
- Brand
- Ambu® SPUR® II Adult Resuscitator
- Company
- Ambu A/S
- Model
- 520611072
- Catalog number
- 520611072
- Device description
- Single Patient Use Resuscitator
- Published
- 2024-02-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| OEV | Cardiopulmonary resuscitation aid kit |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OEV | Cardiopulmonary Resuscitation Aid Kit | Anesthesiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05707480149162 | Package | GS1 | 6 | In Commercial Distribution |
| 05707480149155 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05707480149162 | 05707480149162 | 5707480149162 |
| 05707480149155 | 05707480149155 | 5707480149155 |
GMDN Terms
| Term | Definition |
|---|
| Pulmonary resuscitator, manual, single-use | A non-sterile, 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 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 single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Temperature | -18 Degrees Celsius | 50 Degrees Celsius | |
| Storage Environment Temperature | 15 Degrees Celsius | 25 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 305682023
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
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| 20194717119842 | Regard™ | ROI CPS, LLC | OEV | 2024-07-05 |
| 20194717119774 | Regard™ | ROI CPS, LLC | OEV | 2024-06-25 |
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