FDA.reportPublic FDA data

Babi.Plus

Primary DI
44710810093560
Brand
Babi.Plus
Company
GALEMED CORPORATION
Model
BC23-AU
Catalog number
12.5 cmH O Pressure Relief Manifold
Published
2015-09-24
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 table
CodeName
BYEAttachment, Breathing, Positive End Expiratory Pressure
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090317000
K110383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090317000BABI*PLUS BUBBLE PAP VALVEA Plus Medical2009-05-20BYE
K110383000BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20A Plus Medical2011-08-01BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44710810093560PackageGS112In Commercial Distribution
04710810093562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4471081009356044710810093560
04710810093562047108100935624710810093562

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator IMV supplemental circuit, single-useA device designed to provide mandatory breathes to ventilator patients to supplement the spontaneous respiratory rate. It is typically constructed of plastics and consists of tubing and one-way valves. It will be used as an accessory on older ventilators without built-in intermittent mandatory ventilation (IMV) functions. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656854379
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04710810085550N/A71053AB01252026-03-05
24710810110171N/A5428AM00342026-03-05
24710810112458N/A5429AM00352026-03-05
04710810080586N/A3564AD00492026-03-05
04710810080838N/A5313AM00282026-03-05
04710810081781N/A5304AM00942026-03-05
04710810081811N/A5305AM00952026-03-05
04710810082122N/A3565AD00512026-03-05
04710810082252N/A5315AM00302026-03-05
04710810082269N/A5314AM00292026-03-05
04710810082405N/A5311AM00262026-03-05
04710810082412N/A5312AM00272026-03-05
04710810082429N/A5316AM00312026-03-05
04710810082481N/A5306AM00962026-03-05
04710810082962N/A3551AD00022026-03-05
04710810083327N/A74112AC00532026-03-05
04710810084621N/A2339AR00822026-03-05
04710810084669N/A2437AV00022026-03-05
04710810084850N/A75045AC01712026-03-05
04710810084942N/A0015AM00422026-03-05

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