FDA.reportPublic FDA data

SpeedClean

Primary DI
00841709100208
Brand
SpeedClean
Company
MIDMARK CORPORATION
Model
002-0396-00
Catalog number
002-0396-00
Published
2016-09-23
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
FLESterilizer, Steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023348000MIDMARK M9 ULTRACLAVE STEAM STERILIZERMidmark Corp.2003-03-03FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841709100205PackageGS112In Commercial Distribution
00841709100208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084170910020510841709100205
00841709100208008417091002088417091002080841709100208

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-(800)634-6289telemarketing@midmark.com

Regulatory Flags#

DUNS number
005036025
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841709105791MidmarkIQvitals Zone, w/Nellcor SPO21-200-03202021-05-17
00841709105784MidmarkIQvitals Zone1-200-03102017-04-07
00841709105807MidmarkIQvitals Zone w/Masimo SPO21-200-03302017-04-07
00841709105814MidmarkIQvitals Zone, w/Wireless1-200-03402017-04-07
00841709105821MidmarkIQvitals Zone, w/Nellcor SPO2 and Wirless1-200-03502017-04-07
00841709105838MidmarkIQvitals Zone, w/Masimo SPO2 and Wireless1-200-03602017-04-07
00841709105869MidmarkIQvitals Zone, Non-Wireless4-000-06202017-04-07
00841709105876MidmarkIQvitals Zone, Non-Wireless with Nellcor SPO24-000-06222017-04-07
00841709105883MidmarkIQvitals Zone, Non-Wireless with Masimo SPO24-000-06242017-04-07
00841709105890MidmarkIQvitals Zone, Wireless without SPO24-000-07202017-04-07
00841709105906MidmarkIQvitals Zone, Wireless with Nellcor SPO24-000-07222017-04-07
00841709105913MidmarkIQvitals Zone, Wireless with Masimo SPO24-000-07242017-04-07
00841709107948MidmarkG3G32019-02-08
00841709107979MidmarkG5G52019-02-08
00841709107993MidmarkG6G62019-02-08
00841709108006MidmarkG7G72019-02-08
00841709108020MidmarkG14G142019-02-08
00841709108037MidmarkG10G102019-02-08
00841709108099MidmarkP21/CV3P21/CV32019-02-08
00841709108112MidmarkP21P212019-02-08

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05902533548842Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-15
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