FDA.reportPublic FDA data

S40

Primary DI
10724995090729
Brand
S40
Company
STERIS CORPORATION
Model
S4000
Catalog number
S4000
Device description
The S40 Sterilant Concentrate is a single use peracetic acid-based chemistry used in the SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems. The net contents are 194.2g per cup.
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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
K090036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090036000SYSTEM 1.5 STERILE PROCESSING SYSTEMSTERIS Corporation2010-04-05MED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995090729PackageGS120In Commercial Distribution
00724995090722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499509072910724995090729
00724995090722007249950907227249950907220724995090722

GMDN Terms#

Term, Definition table
TermDefinition
Organic peroxy acid device sterilant, single-useA substance in liquid or powder (reconstituted with water) form that includes an organic peroxy acid (e.g., peracetic acid, perpyruvic acid) as its primary agent intended to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight194Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep upright, dry, away from sunlight, and away from heat or open flame.
Storage Environment Temperature16 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
828222781
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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

Other Devices From This Company#

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10724995023833VERIFYDual SpeciesS3062016-09-09
10724995032798DARTNB113NB1132016-09-09
10724995154735VERIFY SIXCESSPCC072PCC0722019-04-19
10724995154742VERIFY SIXCESSPCC073PCC0732019-04-19
00724995000783Revital-Ox Resert4455N94455N92016-09-07
00724995095017Revital-Ox Resert4455AW4455AW2016-09-07
00724995153779AmscoWarming CabinetDJ060144123132020-06-11
00724995153816AmscoWarming CabinetDJ060144331112020-06-11
00724995161392HarmonyAIRM-Series SuspensionLM99APIT2020-06-17
00724995170493HarmonyAIRG-Series SuspensionLK00162020-05-19
00724995185886HarmonyAIRA-Series Suspension SystemLAS30NC012020-05-28
00724995185893HarmonyAIRA-Series Suspension SystemLAS30NC022020-05-28
00724995185909HarmonyAIRA-Series Suspension SystemLAS30NCND2020-05-28
00724995185916HarmonyAIRA-Series Suspension SystemLAS30NC01T2020-05-28
00724995185923HarmonyAIRA-Series Suspension SystemLAS30NC02T2020-05-28
00724995185930HarmonyAIRA-Series Suspension SystemLAS30NCNDT2020-05-28
00724995185947HarmonyAIRA-Series Suspension SystemLAS52NC012020-05-28
00724995185954HarmonyAIRA-Series Suspension SystemLAS52NC022020-05-28

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Primary DI, Brand, Company table
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