FDA.reportPublic FDA data

Rescuer II Compact CPAP with Nebulizer Kit

Primary DI
B0028800NK0
Brand
Rescuer II Compact CPAP with Nebulizer Kit
Company
B.L.S. Systems Limited
Model
8800-NK
Catalog number
8800-NK
Device description
Rescuer II Compact CPAP System with Large 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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYEAttachment, Breathing, Positive End Expiratory Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122610000PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.2013-08-05BYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0028800NK1PackageHIBCC6In Commercial Distribution
B0028800NK0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
In-line CPAP set, nebulizingA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9053391069tedreesor@blssystemsltd.com

Regulatory Flags#

DUNS number
200103823
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B0026300Rescuer63002025-11-24
B00263050Rescuer630563052025-11-24
B0024050RB0Rescuer4050-RB4050-RB2024-06-12
B0024050RB7Rescuer4050-RB4050-RB2024-06-12
B0024000F0Rescuer4000F4000F2021-01-08
B0027000AD0Rescuer 7000-AD Replacement Suction Canister kit7000-AD7000-AD2018-10-02
B0027000MVP0Rescuer MVP Manual Vacuum Pump7000-MVP7000-MVP2018-10-02
B0023000X0Rescuer3000-X3000-X2023-12-11
B0023000X7Rescuer3000-X3000-X2023-12-11
B0028705NK0Rescuer Emergency CPAP with Medium CPAP Mask8705-NK8705-NK2020-01-06
B0024000UF0Rescuer Manual Resuscitator4000-U-F4000-U-F2021-04-20
B0024010UF0Rescuer Manual Resuscitator4010-U-F4010-U-F2021-04-20
B0024025UF0Rescuer Manual Resuscitator 4025-U-F4025-U-F2021-04-20
B0024050UF0Rescuer Manual Resuscitator4050-U-F4050-U-F2021-04-20
B0026205U0Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)6205-U6205-U2021-04-01
B0026210U0Rescuer O-Mask Oxygen Mask with Universal Tubing6210-U6210-U2021-04-01
B0026200U0Rescuer O-Mask6200-U6200-U2021-04-01
B0026205U7Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)6205-U6205-U2021-04-01
B0026210U7Rescuer O-Mask Oxygen Mask with Universal Tubing6210-U6210-U2021-04-01
B0026100U0Rescuer Flo2Max Oxygen Mask, Large Adult61006100-U2020-11-12

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