FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183528386
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR980-9256
Catalog number
BR980-9256
Device description
CleanTract™, ENT Disposable Suction Pump Kit, consisting of Air Filter Pump, Suction Tubing 10ft, and Fluid canister 1200CC, 5/box
Published
2024-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETFUnit, Examining/Treatment, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETFUnit, Examining/Treatment, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183528386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183528386008401835283868401835283860840183528386

GMDN Terms#

Term, Definition table
TermDefinition
Suction system filter, microbialA screening device intended to be installed within a suction system and which has a membrane pore size small enough to retain bacterial pathogens, thus preventing the environment from becoming infected and decreasing the risk of cross-infection to subsequent patients. It is typically directly connected to the suction system collection bottle/canister, or as a common filter serving more than one bottle/canister through a switching mechanism, or in a tubing line between the suction bottle/canister and the suction pump, or at the suction pump exhaust where driving gases are discarded. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags#

DUNS number
134781207
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840183531430BR Surgical, LLCBR32-47202BR32-472022026-07-22
00840183531980BR Surgical, LLCBR24-67215BR24-672152026-07-22
00840183532017BR Surgical, LLCBR32-47193BR32-471932026-07-22
00840183532024BR Surgical, LLCBR32-47194BR32-471942026-07-22
00840183532031BR Surgical, LLCBR32-47195BR32-471952026-07-22
00840183532093BR Surgical, LLCBR32-38015BR32-380152026-07-22
00840183532154BR Surgical, LLCBR32-24723BR32-247232026-07-22
00840183532161BR Surgical, LLCBR32-23723BR32-237232026-07-22
00840183532178BR Surgical, LLCBR32-23022BR32-230222026-07-22
00840183531232BR Surgical, LLCBR18-21001BR18-210012026-07-21
00840183531720BR Surgical, LLCBR24-25427BR24-254272026-07-21
00840183532185BR Surgical, LLCBR18-68528BR18-685282026-07-21
00840183532192BR Surgical, LLCBR18-68516BR18-685162026-07-21
00840183532222BR Surgical, LLCBR18-27003BR18-270032026-07-21
00840183532239BR Surgical, LLCBR18-27004BR18-270042026-07-21
00840183532383BR Surgical, LLCBR20-10611BR20-106112026-07-21
00840183532475BR Surgical, LLCBR24-19018BR24-190182026-07-21
00840183532499BR Surgical, LLCBR24-32026BR24-320262026-07-21
00840183532628BR Surgical, LLCBR18-30004BR18-300042026-07-21
00840183531423BR Surgical, LLCBR10-18115ABR10-18115A2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183530549BR Surgical, LLCBR Surgical, LLCETF2025-09-05
00840183529918BR Surgical, LLCBR Surgical, LLCETF2025-07-16
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04250365149838ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365149845ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365164084ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365164107ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365164114ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
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04250365190816ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
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