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MediPines Gas Exchange Monitor Starter Kit

Primary DI
00860001261530
Brand
MediPines Gas Exchange Monitor Starter Kit
Company
MEDIPINES CORPORATION
Model
MPSK10
Catalog number
MPSK10
Device description
Breathing Circuit and Nose Clip, Single Use, 10 pieces each
Published
2019-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZLComputer, Oxygen-Uptake
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZLComputer, Oxygen-UptakeAnesthesiology2
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180902000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180902000MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation2019-01-11CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001261530PrimaryGS10
00860001261554Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001261530008600012615308600012615300860001261530
00860001261554008600012615548600012615540860001261554

GMDN Terms#

Term, Definition table
TermDefinition
Nose clip, single-useA device intended to be used to compress the nose externally, to ensure that airflow is exclusively conducted through the mouth during examinations of the pulmonary function (e.g., spirometry), and/or to stop nosebleeds (epistaxis). It is typically constructed of plastic with rubber or foam tips. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9493984670contact@medipines.com

Regulatory Flags#

DUNS number
058309398
Device count
10
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001261516MediPines Single Patient Use Breathing CircuitAGM316AGM316-10, AGM316-50, AGM316-1002019-03-25
00860001261509MediPines Gas Exchange MonitorAGM100AGM1002019-03-25

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Primary DI, Brand, Company table
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