FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183502997
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR900-7955
Catalog number
BR900-7955
Device description
Pressure Hose (10ft) and Stainless Nozzle Fitting (for use with atomizer bottles) for ENT treatment cabinet
Published
2024-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840183502997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183502997008401835029978401835029970840183502997

GMDN Terms#

Term, Definition table
TermDefinition
Medical air low pressure hoseA length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct compressed medical air from a medical air cylinder/terminal unit to a medical device that functions with medical air (e.g., ventilator, anaesthesia unit, anaesthesia system, suctions system, or other medical air dependent device). The gas pressure in the tubing will be low, a "working pressure", having been reduced by a regulator from a higher pressure. The tubing is reinforced with, e.g., woven polyester or cotton and intended for use within a static clinical environment (e.g., intensive care). It is available in various lengths, including standard coil lengths. This is a reusable 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
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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04250365190762ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365190809ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365190816ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
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00840183528492BR Surgical, LLCBR Surgical, LLCETF2024-10-28
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