FDA.reportPublic FDA data

enspire

Primary DI
00724995217440
Brand
enspire
Company
Corporation Steris Canada
Model
enspire 300 Series
Catalog number
ENHLD300208VWD
Device description
The enspire 300 Series Automated Endoscope Reprocessor 208V, Vented, Wall Drain is designed to effectively test, clean, high level disinfect, rinse and air purge up to two heat-sensitive, immersible, reusable, semi-critical devices including, but not limited to, GI flexible endoscopes such as bronchoscopes, gastroscopes, and duodenoscopes; or up to six non-channeled naso-endoscopes.
Published
2024-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEDSterilant, medical devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEDSterilant, Medical DevicesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230560000
K232918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230560000enspire 300 Series Automated Endoscope Reprocessor SystemSTERIS Corporation2023-07-21NZA
K232918000enspire 300 Series Automated Endoscope ReprocessorSTERIS Corporation2023-10-03NZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995217440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995217440007249952174407249952174400724995217440

GMDN Terms#

Term, Definition table
TermDefinition
Instrument non-thermal chemical disinfectorAn electrically-powered unit intended to be used for the non-thermal chemical disinfection of probes, surgical instruments, and/or endoscopes, and their accessories (e.g., heat-sensitive instruments). It may include washing features and may have built-in features to circulate cleaning and disinfectant solutions through a device lumen; some types may also have built-in drying features. It is not intended for device sterilization.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
202659140
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995217433enspireenspire 300 SeriesENHLD300208VFD2024-04-17
00724995217457enspireenspire 300 SeriesENHLD300208NVFD2024-04-17
00724995217464enspireenspire 300 SeriesENHLD300208NVWD2024-04-17
00724995217471enspireenspire 300 SeriesENHLD300480VFD2024-04-17
00724995217488enspireenspire 300 SeriesENHLD300480VWD2024-04-17
00724995217495enspireenspire 300 SeriesENHLD300480NVFD2024-04-17
00724995217501enspireenspire 300 SeriesENHLD300480NVWD2024-04-17
00724995214395AMSCO1215FW121012021-08-13
00724995214401AMSCO1215FW121022021-08-13
00724995214418AMSCO1215FW121122021-08-13
00724995214425AMSCO1215FW121072021-08-13
00724995214432AMSCO1215FW121172021-08-13
00724995214449AMSCO1215FW121052021-08-13
00724995214456AMSCO1215FW121152021-08-13
00724995214463AMSCO1215FW121032021-08-13
00724995214470AMSCO1215FW121132021-08-13
00724995176563AMSCO7052HPFH180822020-09-04
00724995176648AMSCO7053HPFH190822020-09-04
00724995192648Reliance VisionSingle ChamberFH050422020-09-04
00724995192655Reliance VisionSingle ChamberFH050432020-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858293006939PeracidinREPROCESSING PRODUCTS CORPORATIONMED2026-07-24
00858293006946PeracidinREPROCESSING PRODUCTS CORPORATIONMED2026-07-24
05056030403057Backflush Aspiration HandpiecesSTERIMEDIX LIMITEDMED2026-07-21
05056030403613Hydrodissection CannulaeSTERIMEDIX LIMITEDMED2026-07-21
15056030400688Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403785Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403792Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403808Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403815Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403822Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403839Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403846Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403853Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403860Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403877Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403884Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403891Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403907Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403914Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403921Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403938Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403945Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403952Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030404089Anterior CannulaSTERIMEDIX LIMITEDMED2026-02-24
10705037048755AEROZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10885862658166EXACTECHExactech, Inc.MED2025-11-14
10885862658173EXACTECHExactech, Inc.MED2025-11-14
10885862658197EXACTECHExactech, Inc.MED2025-11-14
10885862658203EXACTECHExactech, Inc.MED2025-11-14
10885862658210EXACTECHExactech, Inc.MED2025-11-14