BF

Primary DI
00026072023655
Brand
BF
Company
Allied Medical, LLC
Model
81351
Device description
UNIV/APS'AP4 PART A CIR-
Published
2024-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CBOAttachment, Intermittent Mandatory Ventilation (Imv)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBOAttachment, Intermittent Mandatory Ventilation (Imv)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K760680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K760680000INTERMITTENT MANDATORY VENTILATIONB & F Medical Products, Inc.1976-09-27CBO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40026072023653PackageGS150In Commercial Distribution
00026072023655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4002607202365340026072023653
00026072023655000260720236550260720236550026072023655

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Regulatory Flags#

DUNS number
119066872
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00026072021439PC11-20-00112024-09-17
00026072026861ALLIED MEDICAL LLC01-90-310001-90-31002025-10-13
00026072026878ALLIED MEDICAL LLC01-90-3100-KIT01-90-3100-KIT2025-10-13
00026072026892ALLIED MEDICAL LLC01-90-392801-90-39282025-10-13
00026072026908ALLIED MEDICAL LLC01-90-3928-KIT 01-90-3928-KIT 2025-10-13
00026072001479EMLPEEP2024-05-28
00026072012161BF645502024-05-28
00026072020548BF64095-AHP2024-10-11
00026072022177EML599-0102024-05-28
00026072022184EML599-0302024-05-28
00026072022191EML599-1302024-05-28
00026072022207EML599-1402024-05-28
00026072022214EML599-1802024-05-28
00026072022238EML599-1902024-05-28
00026072022252EML599-2802024-05-28
00026072022924BF338002024-10-11
00026072022931BF338012024-05-28
00026072023006BF332072024-10-11
00026072023013BF640072024-10-11
00026072023037BF640412024-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40026072023653BFAllied Medical, LLCCBO2024-10-11
14026704656803HUDSON RCITELEFLEX INCORPORATEDCBO2019-05-09
24026704656800HUDSON RCITELEFLEX INCORPORATEDCBO2019-05-09
10885403164057AirLifeCarefusion CorporationCBO2016-09-01
50885403164055AirLifeCarefusion CorporationCBO2016-09-01
04026704595075HUDSON RCITELEFLEX INCORPORATEDCBO2015-10-16
24026704595079HUDSON RCITELEFLEX INCORPORATEDCBO2015-10-16