FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183513078
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR980-9255
Catalog number
BR980-9255
Device description
Suction Pump kit for ENT Workstation, includes filter, black reusable suction tubing and 1200cc canister, 5/box
Published
2024-07-23
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
00840183513078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183513078008401835130788401835130780840183513078

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
00840183530679BR Surgical, LLCBR900-5050-ACSBR900-5050-ACS2025-09-05
00840183529000BR Surgical, LLCBR900-5050-OLYSTZBR900-5050-OLYSTZ2024-11-07
00840183526986BR Surgical, LLCBR900-7110BR900-71102024-07-23
00840183500238BR Surgical, LLCBR900-5050BR900-50502024-07-22
00840183501464BR Surgical, LLCBR900-5050-OLYBR900-5050-OLY2024-07-22
00840183501822BR Surgical, LLCBR900-3105BR900-31052024-07-22
00840183502072BR Surgical, LLCBR900-5050-ACMIBR900-5050-ACMI2024-07-22
00840183510244BR Surgical, LLCBR900-5050-ASBR900-5050-AS2024-07-22
00840183512149BR Surgical, LLCBR900-5050-ACOBR900-5050-ACO2024-07-22
00840183514891BR Surgical, LLCBR900-5050-WOLFBR900-5050-WOLF2024-07-22
00840183517861BR Surgical, LLCBR900-3103BR900-31032024-07-22
00840183522131BR Surgical, LLCBR900-5050-10BR900-5050-102024-07-22
00840183522957BR Surgical, LLCBR900-5050-OLY-6BR900-5050-OLY-62024-07-22
00840183523244BR Surgical, LLCBR900-5050-OLACBR900-5050-OLAC2024-07-22
00840183523312BR Surgical, LLCBR900-5050-PTXBR900-5050-PTX2024-07-22
00840183525491BR Surgical, LLCBR900-5050-7BR900-5050-72024-07-22
00840183531065BR Surgical, LLCBR08-36111SCSBR08-36111SCS2025-09-29
00840183531089BR Surgical, LLCBR18-48273BR18-482732025-09-29
00840183531133BR Surgical, LLCBR12-32114BR12-321142025-09-29
00840183531171BR Surgical, LLCBR18-15003BR18-150032025-09-29

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
04250365149791ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365149807ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365149814ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365149821ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
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
04250365166187ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365174960ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365174977ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365174984ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
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04250365175677ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365190762ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365190809ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365190816ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
00840183528447BR Surgical, LLCBR Surgical, LLCETF2024-11-07
00840183528461BR Surgical, LLCBR Surgical, LLCETF2024-11-07
00840183528300BR Surgical, LLCBR Surgical, LLCETF2024-11-06
00840183528478BR Surgical, LLCBR Surgical, LLCETF2024-11-06
00840183528485BR Surgical, LLCBR Surgical, LLCETF2024-11-06
00840183528386BR Surgical, LLCBR Surgical, LLCETF2024-10-29
00840183528492BR Surgical, LLCBR Surgical, LLCETF2024-10-28
00840183528508BR Surgical, LLCBR Surgical, LLCETF2024-10-28
00840183528515BR Surgical, LLCBR Surgical, LLCETF2024-10-28
00840183502997BR Surgical, LLCBR Surgical, LLCETF2024-07-23