FDA.report

Compliance BronchKit™

Primary DI
00840253116031
Brand
Compliance BronchKit™
Company
BOSTON SCIENTIFIC CORPORATION
Model
CBK-881
Catalog number
CBK-881
Device description
Compliance BronchKit™
Published
2018-11-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
MNLACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840253116031PackageGS120In Commercial Distribution
00840253119469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840253116031008402531160318402531160310840253116031
00840253119469008402531194698402531194690840253119469

GMDN Terms

TermDefinition
Endoscope cleaning kitA collection of devices and supplies intended for performing manual cleaning of endoscopes. Items include brushes of several sizes, detergents, and applicators. This manual cleaning is typically performed before endoscope sterilization. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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