FDA.reportPublic FDA data

BFlex™

Primary DI
00879123009012
Brand
BFlex™
Company
Verathon Medical (Canada) ULC
Model
BFlex™ 2 SamplePro™
Catalog number
0574-0263
Device description
BFlex™ 2 SamplePro™ specimen sampler
Published
2026-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMHContainer, Specimen, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10879123009019PackageGS15In Commercial Distribution
00879123009012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087912300901910879123009019
00879123009012008791230090128791230090120879123009012

GMDN Terms#

Term, Definition table
TermDefinition
Bronchoscopic specimen collection containerA noninvasive receptacle containing no additives intended to be used for the collection/sampling, and preservation and/or transport, of a bronchial fluid specimen during a bronchoscopic therapeutic procedure [e.g., bronchoalveolar lavage (BAL), bronchial wash], typically for subsequent microbiological analysis. It is designed to be attached to a bronchoscope connected to a suction source. This is a single-use device.

Regulatory Flags#

DUNS number
243738320
Device count
1
DM exempt
false
Premarket exempt
true
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
00879123009340GlideScope®GlideScope® Core™ 10 FHD Essential Configuration0270-1212-FHD2026-05-29
00879123009357GlideScope®GlideScope® Core™ 15 FHD Essential Configuration0270-1213-FHD2026-05-29
00840432200056Verathon®Verathon® Essential Workstation0800-07002026-05-28
00840432200001CFlex™Single-Use Cystoscope, Standard Deflection0570-04552026-05-15
00840432200018CFlex™Single-Use Cystoscope, Reverse Deflection0570-04592026-05-15
00840432200063CystoView™Essential Configuration with Holder and QuickConne0270-12032026-05-15
00840432200117CystoView™CystoView™ Monitor0570-04652026-05-15
00840432200308CystoView™Clamp Kit Configuration with Holder and QuickConne0270-12022026-05-15
00840432200315CystoView™Clamp Kit Configuration with QuickConnect™ Cable0270-12012026-05-15
00840432200322CystoView™Monitor with QuickConnect™ Cable0270-12002026-05-15
00879123007841GlideScope®ClearFit™ Video Baton0570-04252025-08-01
00879123008381GlideScope®ClearFit™ Hyperangle 3 Cover0574-02422025-08-01
00879123008398GlideScope®ClearFit™ Hyperangle 4 Cover0574-02432025-08-01
00879123008428GlideScope®ClearFit™ Miller 2 Cover0574-02472025-08-01
00879123008442GlideScope®ClearFit™ MAC 2 Cover0574-02442025-08-01
00879123008459GlideScope®ClearFit™ MAC 3 Cover0574-02452025-08-01
00879123008466GlideScope®ClearFit™ MAC 4 Cover0574-02462025-08-01
00879123007612GlideScope®GlideScope® Go™ 2 Monitor Configuration0270-11862025-08-01
00879123007643GlideScope®GlideScope® Core™ 10 FHD Premium Configuration0270-1187-FHD2025-08-01
00879123007759GlideScope®GlideScope® Core™ 15 FHD Premium Configuration0270-1188-FHD2025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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H108117041CorningCorning IncorporatedFMH2025-10-28
10192253051490DoverCardinal Health 200, LLCFMH2025-09-30
10192253051513DoverCardinal Health 200, LLCFMH2025-09-30
10198459304637MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-08-18
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10080196035298MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
10198459351327MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-06-02
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10192253051636PrecisionCardinal Health 200, LLCFMH2025-02-19
10198459247897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10198459249303Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10197344039517MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-01-31
10198459203176Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-12-08
10198459190544Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-24
10198459179860Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
10198459181702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
H1084313371CorningCorning IncorporatedFMH2024-10-29
H1084313381CorningCorning IncorporatedFMH2024-10-29
H1084313471CorningCorning IncorporatedFMH2024-10-29
H1084316231CorningCorning IncorporatedFMH2024-10-29
H1084316241CorningCorning IncorporatedFMH2024-10-29
H1084316251CorningCorning IncorporatedFMH2024-10-29