FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403195990
Brand
V. Mueller
Company
STERIS CORPORATION
Model
R1187-PURPLE
Catalog number
R1187PURPLE
Device description
GENESIS LID ASSEMBLY QUARTER-LENGTH CONTAINER PURPLE
Published
2018-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142529000Genesis Reusable Rigid Container SystemCarefusion 2200, Inc.2015-01-08KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403195990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540319599010885403195990

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization containerA receptacle designed to hold wrapped and/or unwrapped surgical instruments (e.g. hand-held tools, surgical powered drills, hoses) during sterilization and for their subsequent storage. The container is permeable in order to allow moisture to escape from within after the sterilization process is finished, whilst protecting the contents from being contaminated. It may have features such as an expiry date label, sterile breathing filter, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17
10885403018992V. MuellerCD1-5CCD15C2017-11-17
10885403019029V. MuellerCD1-6BCD16B2017-11-17
10885403019036V. MuellerCD1-6CCD16C2018-01-22
10885403019074V. MuellerCD1-7CDLCD17CDL2018-01-22
10885403125676V. MuellerCD1-8BDLCD18BDL2018-01-22
10885403186141V. MuellerDINCD1-5BDINCD15B2018-03-15
10885403186158V. MuellerDINCD1-5CDINCD15C2018-03-15
10885403186165V. MuellerDINCD1-6BDINCD16B2018-03-15
10885403186172V. MuellerDINCD1-6CDINCD16C2018-08-13
10885403193798V. MuellerCD1-4B-GOLDCD14BGOLD2017-11-17
10885403193804V. MuellerCD1-4B-PURPLECD14BPURPLE2017-11-17
10885403193811V. MuellerCD1-4B-BLUECD14BBLUE2017-11-17
10885403193828V. MuellerCD1-4B-GREENCD14BGREEN2017-11-17
10885403193835V. MuellerCD1-4B-REDCD14BRED2017-11-17
10885403193842V. MuellerCD1-4B-BLACKCD14BBLACK2017-11-17
10885403193859V. MuellerCD1-5B-GOLDCD15BGOLD2017-11-17
10885403193866V. MuellerCD1-5B-PURPLECD15BPURPLE2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640094016INSTRUSAFESummit Medical, Inc.KCT2026-08-19
00385640094023INSTRUSAFESummit Medical, Inc.KCT2026-08-19
00385640093972INSTRUSAFESummit Medical, Inc.KCT2026-08-18
00385640093989INSTRUSAFESummit Medical, Inc.KCT2026-08-18
00385640094009INSTRUSAFESummit Medical, Inc.KCT2026-08-18
00724995239879V. MuellerSteris CorporationKCT2026-08-18
00724995239886V. MuellerSteris CorporationKCT2026-08-18
00724995239893V. MuellerSteris CorporationKCT2026-08-18
00724995240615V. MuellerSteris CorporationKCT2026-08-18
00724995240622V. MuellerSteris CorporationKCT2026-08-18
00724995240639V. MuellerSteris CorporationKCT2026-08-18
00724995240714V. MuellerSteris CorporationKCT2026-08-18
00724995240721V. MuellerSteris CorporationKCT2026-08-18
00724995240738V. MuellerSteris CorporationKCT2026-08-18
00724995240745V. MuellerSteris CorporationKCT2026-08-18
00724995240752V. MuellerSteris CorporationKCT2026-08-18
00724995240769V. MuellerSteris CorporationKCT2026-08-18
00724995240776V. MuellerSteris CorporationKCT2026-08-18
00724995240783V. MuellerSteris CorporationKCT2026-08-18
00724995240790V. MuellerSteris CorporationKCT2026-08-18
00724995240806V. MuellerSteris CorporationKCT2026-08-18
00724995240813V. MuellerSteris CorporationKCT2026-08-18
00724995240820V. MuellerSteris CorporationKCT2026-08-18
00724995240837V. MuellerSteris CorporationKCT2026-08-18
00724995240844V. MuellerSteris CorporationKCT2026-08-18
00724995240851V. MuellerSteris CorporationKCT2026-08-18
00724995240868V. MuellerSteris CorporationKCT2026-08-18
00724995240875V. MuellerSteris CorporationKCT2026-08-18
00724995240882V. MuellerSteris CorporationKCT2026-08-18
00724995240899V. MuellerSteris CorporationKCT2026-08-18