FDA.reportPublic FDA data

Midmark

Primary DI
00841709121777
Brand
Midmark
Company
MIDMARK CORPORATION
Model
1-300-0400
Catalog number
1-300-0400
Device description
Digital Vital Signs Device, Masimo with RRp
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter
DXNSystem, measurement, blood-pressure, non-invasive
FLLContinuous Measurement Thermometer
MWIMonitor, physiological, patient (without arrhythmia detection or alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253196000Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation2026-06-12MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841709121777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709121777008417091217778417091217770841709121777

Contacts#

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

Regulatory Flags#

DUNS number
005036025
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
00841709121746Midmark1-300-01001-300-01002026-10-30
00841709121753Midmark1-300-02001-300-02002026-10-30
00841709121760Midmark1-300-03001-300-03002026-10-30
00841709124808Ritter228-001228-0012026-08-27
00841709124815Ritter228-002228-0022026-08-27
00841709124822Ritter228-003228-0032026-08-27
00841709124846Ritter229-002229-0022026-08-27
00841709124853Ritter229-003229-0032026-08-27
00841709109669Midmark626-005626-0052019-10-04
00841709109676Midmark626-006626-0062019-10-04
00841709105920Midmark626-001626-0012018-02-27
00841709105937Midmark626-002626-0022018-02-27
00841709105944Midmark626-003626-0032018-02-27
00841709105951Midmark626-004626-0042018-02-27
00841709105968Midmark627-011627-0112018-02-27
00841709105975Ritter225-002225-0022018-02-27
00841709105982Ritter225-003225-0032018-02-27
00841709105999Ritter224-001224-0012018-02-27
00841709106002Ritter224-002224-0022018-02-27
00841709106019Ritter224-003224-0032018-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841709121746MidmarkMIDMARK CORPORATIONDQA2026-10-30
00841709121746MidmarkMIDMARK CORPORATIONFLL2026-10-30
00841709121746MidmarkMIDMARK CORPORATIONMWI2026-10-30
00841709121746MidmarkMIDMARK CORPORATIONDXN2026-10-30
00841709121753MidmarkMIDMARK CORPORATIONDQA2026-10-30
00841709121753MidmarkMIDMARK CORPORATIONMWI2026-10-30
00841709121753MidmarkMIDMARK CORPORATIONFLL2026-10-30
00841709121753MidmarkMIDMARK CORPORATIONDXN2026-10-30
00841709121760MidmarkMIDMARK CORPORATIONDQA2026-10-30
00841709121760MidmarkMIDMARK CORPORATIONFLL2026-10-30
00841709121760MidmarkMIDMARK CORPORATIONMWI2026-10-30
00841709121760MidmarkMIDMARK CORPORATIONDXN2026-10-30
06946725550021APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550038APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550045APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725519196APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519202APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519219APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519226APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519233APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519240APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519257APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519264APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519271APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519288APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519295APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519301APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519318APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519325APKAPK Technology Co.,Ltd.DQA2026-03-13
06946725519332APKAPK Technology Co.,Ltd.DQA2026-03-13