FDA.reportPublic FDA data

Midmark

Primary DI
00841709100314
Brand
Midmark
Company
MIDMARK CORPORATION
Model
9A599001
Catalog number
9A599001
Device description
Records and prints sterilization cycle data including time, chamber temperature, and pressure
Published
2019-08-01
Public version status
New
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
K163337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163337000Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerMidmark Corporation2017-08-31FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841709100314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709100314008417091003148417091003140841709100314

GMDN Terms#

Term, Definition table
TermDefinition
Ink printerA colour or monochrome printer designed to propel droplets of ink directly onto a medium (typically paper) to produce a printed image.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)643-6275support@midmark.com

Regulatory Flags#

DUNS number
005036025
Device count
1
Serial number
true
Manufacturing date on label
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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Primary DI, Brand, Company table
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07640397422295BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422301BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422318BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422325BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07629999282957Enbio-Autoclave Control FirmwareEnbio Group AGFLE2026-03-02
07629999900769Enbio PRO (ver. USA/CAN)Enbio Group AGFLE2026-03-02
05902533549214Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-02-16
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07640397421755STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
07640397421793STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
06972615108003icanclaveNingbo Ican Machines Co., Ltd.FLE2025-12-19
05904165664280EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
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06971608311505ADSGuangzhou Ajax Medical Equipment Co., Ltd.FLE2025-09-15
05902533548842Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-15
05902533548828Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
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