Home GUDID B0028805NK1 Rescuer II Compact CPAP System with Medium Deluxe
Primary DI B0028805NK1
Brand Rescuer II Compact CPAP System with Medium Deluxe
Company B.L.S. Systems Limited
Model 8805-NK
Catalog number 8805-NK
Device description Rescuer II Compact CPAP with Medium Deluxe CPAP Mask and Nebulizer Kit
Published 2018-10-02
Public version status New
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 B0028805NK1 Package HIBCC 6 In Commercial Distribution B0028805NK0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition In-line CPAP set, nebulizing A portable collection of devices intended to be connected to a medical gas supply to assist noninvasive ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It includes an in-line/gas-line CPAP device (a small plastic unit intended to establish a gas pressure proportional to gas flow rate), a face mask, a nebulizer, and may include additional components (e.g., manometer, flowmeter, tubing, mask strap). This is a reusable device once the consumable products have been replenished.
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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