FDA.reportPublic FDA data

BioTrend®

Primary DI
00763000167332
Brand
BioTrend®
Company
MEDTRONIC, INC.
Model
R95198-04
Device description
INS R95198-04 BIOTREND UNIV 8LDOM
Published
2019-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTYSENSOR, BLOOD-GAS, IN-LINE, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTYSensor, Blood-Gas, In-Line, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093650000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093650000BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEMMedtronic, Inc.2010-02-17DTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000167332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000167332007630001673327630001673320763000167332

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal blood gas/pH monitorA mains electricity (AC-powered) device designed for the continuous measurement and display of blood gas and related parameters when blood is circulated outside of the body in a closed system. It is typically used with an appropriate sensor or sensor cassette inserted into external tubing to measure parameters such as partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, temperature, haemoglobin (Hb), and hematocrit (Hct). It is typically used with a cardiopulmonary bypass system, or bedside for a patient with respiratory failure (e.g., obstructive lung disease, severe asthma) or severe pulmonary hypertension after cardiac surgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The device should only be used in a hospital environment away from sources ofhigh-intensity electromagnetic disturbances, such as MRI devices.
Storage Environment Atmospheric Pressure73 KiloPascal101 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000216269BioTrend®MEDTRONIC, INC.DTY2020-01-19
00763000216276BioTrend®MEDTRONIC, INC.DTY2019-12-23
00763000216221BioTrend®MEDTRONIC, INC.DTY2019-12-13
00763000216238BioTrend®MEDTRONIC, INC.DTY2019-12-13
00613994750280Bio Trend®MEDTRONIC, INC.DTY2016-09-04
00613994638649BioTrend®MEDTRONIC, INC.DTY2016-05-19
00613994638656BioTrend®MEDTRONIC, INC.DTY2016-05-19
00643169200906BioTrend®MEDTRONIC, INC.DTY2016-04-29