FDA.report

BR Surgical, LLC

Primary DI
00840183522018
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR900-7987
Catalog number
BR900-7987
Device description
Powder Blower with polypropylene top
Published
2024-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)

Product Code Classifications

CodeDeviceSpecialtyClass
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183522018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183522018008401835220188401835220180840183522018

GMDN Terms

TermDefinition
Atomizer, non-ventilatory A non-powered, non-ventilatory device intended to provide liquid medication in an aerosolized airborne form for a patient to breathe. It is typically hand-operated. Unlike a nebulizer this devices lacks a baffle, therefore the particle size of the aerosol is not stabilized.

Sterilization Methods

Method

Contacts

PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags

DUNS number
134781207
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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