SLIMLINE
- Primary DI
- 00619498368136
- Brand
- SLIMLINE
- Company
- RESMED LIMITED
- Model
- 36813
- Catalog number
- 36813
- Device description
- SLIMLINE TUBING GEN II CPL
- Published
- 2016-09-14
- 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 |
|---|
| BYX | Tubing, Pressure And Accessories |
| BZD | Ventilator, Non-Continuous (Respirator) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00619498368136 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00619498368136 | 00619498368136 | 619498368136 | 0619498368136 |
GMDN Terms
| Term | Definition |
|---|
| Home CPAP unit | A portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Atmospheric Pressure | 70 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 5 Percent (%) Relative Humidity | 95 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -4 Degrees Fahrenheit | 140 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 751149311
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- 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
- false
- Sterilization required before use
- false
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