FDA.reportPublic FDA data

Portable O2 System - Manual Resuscitator

Primary DI
00813830022834
Brand
Portable O2 System - Manual Resuscitator
Company
ACCUTRON, INC.
Model
38006
Catalog number
38006
Published
2023-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BTMVentilator, Emergency, Manual (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910040000AMBU SIR 2 (SILICONE RESUSCITATOR), ADULTAmbu, Inc.1991-05-28BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813830022834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813830022834008138300228348138300228340813830022834

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, reusableA 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 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
088302096
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
90813830028822Oxygen Connector, MQC x O2 DISS, Universal33969339692019-11-06
00813830020236FRU, Cartridge Body N2O24107241072025-06-30
00810085200130Ultra PC% Oral Surgery Package H36800-OS36800-OS2025-05-14
00813830021721Recessed QC Outlet Vacuum34011340112023-09-22
00813830021844Surface Q/C Triple Outlet34060340602023-09-22
00813830022032Surface Q/C Dual Outlet34076340762023-09-22
00813830022049Surface Q/C O2 Outlet34077340772023-09-22
00813830022056Surface Imperial N2 Outlet34078-I34078-I2023-09-22
00813830022063Surface Schrader N2 Outlet34078-S34078-S2023-09-22
00813830022070Surface Q/C Vacuum Outlet34079340792023-09-22
00813830021677Recessed Q/C Triple Outlet34004340042023-09-14
00813830021684Recessed Q/C Dual Outlet34005340052023-09-14
00813830021691Recessed Q/C O2 Outlet34009340092023-09-14
00813830021660Floor Q/C Dual Outlet34003340032016-09-27
00813830021707Recessed Imperial Nitrogen Outlet34010-I34010-I2016-09-28
00813830021714Recessed Schrader Q/C Outlet Nitrogen34010-S34010-S2016-09-28
00813830021738Micro In-Line Triple DISS Outlet Kit34012-334012-32016-09-28
00813830021745Micro In-Line Triple DISS Outlet Kit, NS34012-3-NS34012-3-NS2016-09-28
00813830021752Micro Outlet, Dual, DISS34013340132016-09-28
00813830021769Micro In-Line Dual DISS Outlet Kit34013-334013-32016-09-27

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