Home GUDID B20087101 Rescuer Emergency CPAP System
Primary DI B20087101
Brand Rescuer Emergency CPAP System
Company B.L.S. Systems Limited
Model 8710
Catalog number 8710
Device description Rescuer Emergency CPAP Systems with small CPAP mask and pre-attached bonnet is a single patient use disposable CPAP generator to be used on patients e
Published 2015-05-05
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 table Code Name BYE Attachment, Breathing, Positive End Expiratory Pressure
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B20087101 Package HIBCC 6 In Commercial Distribution B20087100 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition CPAP/BPAP face mask, single-use A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -40 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 200103823 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 true 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 table Primary DI Brand Model Catalog Published B0026300 Rescuer 6300 2025-11-24 B00263050 Rescuer 6305 6305 2025-11-24 B0024050RB0 Rescuer 4050-RB 4050-RB 2024-06-12 B0024050RB7 Rescuer 4050-RB 4050-RB 2024-06-12 B0024000F0 Rescuer 4000F 4000F 2021-01-08 B0027000AD0 Rescuer 7000-AD Replacement Suction Canister kit 7000-AD 7000-AD 2018-10-02 B0027000MVP0 Rescuer MVP Manual Vacuum Pump 7000-MVP 7000-MVP 2018-10-02 B0023000X0 Rescuer 3000-X 3000-X 2023-12-11 B0023000X7 Rescuer 3000-X 3000-X 2023-12-11 B0028705NK0 Rescuer Emergency CPAP with Medium CPAP Mask 8705-NK 8705-NK 2020-01-06 B0024000UF0 Rescuer Manual Resuscitator 4000-U-F 4000-U-F 2021-04-20 B0024010UF0 Rescuer Manual Resuscitator 4010-U-F 4010-U-F 2021-04-20 B0024025UF0 Rescuer Manual Resuscitator 4025-U-F 4025-U-F 2021-04-20 B0024050UF0 Rescuer Manual Resuscitator 4050-U-F 4050-U-F 2021-04-20 B0026205U0 Rescuer O-Mask with Universal Oxygen Tubing (Small Adult) 6205-U 6205-U 2021-04-01 B0026210U0 Rescuer O-Mask Oxygen Mask with Universal Tubing 6210-U 6210-U 2021-04-01 B0026200U0 Rescuer O-Mask 6200-U 6200-U 2021-04-01 B0026205U7 Rescuer O-Mask with Universal Oxygen Tubing (Small Adult) 6205-U 6205-U 2021-04-01 B0026210U7 Rescuer O-Mask Oxygen Mask with Universal Tubing 6210-U 6210-U 2021-04-01 B0026100U0 Rescuer Flo2Max Oxygen Mask, Large Adult 6100 6100-U 2020-11-12
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