BF

Primary DI
40026072023653
Brand
BF
Company
Allied Medical, LLC
Model
81351
Device description
UNIV/APS'AP4 PART A CIR-
Published
2024-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119066872
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
false
Expiration date on label
false
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
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
00026072023655BFAllied 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