SPUR® II Pediatric Resuscitatorw/ Manometer
- Primary DI
- 05707480109579
- Brand
- SPUR® II Pediatric Resuscitatorw/ Manometer
- Company
- Ambu A/S
- Model
- 530614030
- Catalog number
- 530614030
- Device description
- SPUR II Ped, Neo, Inf, Tod FM
- 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
- true
Product Codes
| Code | Name |
|---|
| BTM | Ventilator, emergency, manual (resuscitator) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | Anesthesiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05707480109586 | Package | GS1 | 6 | In Commercial Distribution |
| 05707480109579 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05707480109586 | 05707480109586 | 5707480109586 |
| 05707480109579 | 05707480109579 | 5707480109579 |
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. |
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 | 60 Degrees Celsius | |
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
- true
- 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
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