FDA.reportPublic FDA data

Compliance EndoKit™

Primary DI
00840253117830
Brand
Compliance EndoKit™
Company
BOSTON SCIENTIFIC CORPORATION
Model
CEK-834
Catalog number
CEK-834
Device description
Compliance EndoKit
Published
2018-11-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNLACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840253114686PackageGS120In Commercial Distribution
00840253117830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840253114686008402531146868402531146860840253114686
00840253117830008402531178308402531178300840253117830

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
021717889
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14
08714729880318Rhythmia™ Mapping SystemM004RBLMR1002016-09-24
08714729938736RHYTHMIA HDx™M004RH20010M004RH200102017-05-03
08714729832089Rubicon™ 18H749392390180902016-09-24
08714729832096Rubicon™ 35H749392400350902016-09-24
08714729832102Rubicon™ 35H749392400351502016-09-24
08714729832119Rubicon™ 35H749392400350602016-09-24
08714729832126Rubicon™ 35H749392400351302016-09-24
08714729832133Rubicon™ 14H749392120141302016-09-24
08714729832140Rubicon™ 14H749392120141502016-09-24
08714729832157Rubicon™ 18H749392390181302016-09-24
08714729832164Rubicon™ 18H749392390181502016-09-24
00191506019563Rubicon™ ControlH749394321409A0H749394321409A02024-02-16
00191506019587Rubicon™ ControlH749394321413A0H749394321413A02024-02-16
00191506019600Rubicon™ ControlH749394321415A0H749394321415A02024-02-16
00191506019624Rubicon™ ControlH749394321809A0H749394321809A02024-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04580826926488PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926648PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926679PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926686PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926761PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826927232PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826928369PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826928376PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931789PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931796PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931802PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
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