FDA.reportPublic FDA data

Broncho Sampler

Primary DI
16970462546716
Brand
Broncho Sampler
Company
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Model
BS01
Published
2026-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
16970462546716PackageGS11In Commercial Distribution
26970462546713PackageGS110In Commercial Distribution
06970462546719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697046254671616970462546716
2697046254671326970462546713
06970462546719069704625467196970462546719

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
403655303
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
06970462546719Broncho SamplerBS012026-02-10
06970462546856Stone Collector180ML-L2026-02-10
06970462547457Single-use Ureteral Access SheathY-08-362026-02-10
06970462547464Single-use Ureteral Access SheathY-08-402026-02-10
06970462547471Single-use Ureteral Access SheathY-08-452026-02-10
06970462547488Single-use Ureteral Access SheathY-08-502026-02-10
06970462547495Single-use Ureteral Access SheathY-08-552026-02-10
06970462547501Single-use Ureteral Access SheathY-09-362026-02-10
06970462547518Single-use Ureteral Access SheathY-09-452026-02-10
06970462547525Single-use Ureteral Access SheathY-09-552026-02-10
06970462547532Single-use Ureteral Access SheathY-10-362026-02-10
06970462547549Single-use Ureteral Access SheathY-10-452026-02-10
06970462547556Single-use Ureteral Access SheathY-10-552026-02-10
06970462547563Single-use Ureteral Access SheathY-11-362026-02-10
06970462547570Single-use Ureteral Access SheathY-11-452026-02-10
06970462547587Single-use Ureteral Access SheathY-11-552026-02-10
06970462547594Single-use Ureteral Access SheathY-12-362026-02-10
06970462547600Single-use Ureteral Access SheathY-12-452026-02-10
06970462547617Single-use Ureteral Access SheathY-12-552026-02-10
06970462546825Irrigation PumpPP-012026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00879123009012BFlex™Verathon Medical (Canada) ULCFMH2026-05-29
H1084306551CorningCorning IncorporatedFMH2026-01-26
H1083540141Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540171Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540201Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H108117391CorningCorning IncorporatedFMH2026-01-14
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
10198459382963MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-07-02
10080196035298MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
10198459351327MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-06-02
10198459319990Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-04-18
10193489013467MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-03-20
10198459295270Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-03-16
10198459277122Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-03-02
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