FDA.reportPublic FDA data

MediPines Single Patient Use Breathing Circuit

Primary DI
00860001261516
Brand
MediPines Single Patient Use Breathing Circuit
Company
MEDIPINES CORPORATION
Model
AGM316
Catalog number
AGM316-10, AGM316-50, AGM316-100
Device description
Breathing Circuit Kit, Single Patient Use, 10
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
00860001261523PackageGS15In Commercial Distribution
00860001261561PackageGS110In Commercial Distribution
00860001261516PrimaryGS10
00860001261547Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001261523008600012615238600012615230860001261523
00860001261561008600012615618600012615610860001261561
00860001261516008600012615168600012615160860001261516
00860001261547008600012615478600012615470860001261547

GMDN Terms#

Term, Definition table
TermDefinition
Breathing mouthpiece, single-useA device designed to be inserted into a patient's mouth to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that provides an appropriate gastight seal (i.e., with a patient's lips) and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector). 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 Pressure-25 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9493984670contact@medipines.com

Regulatory Flags#

DUNS number
058309398
Device count
10
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
00860001261530MediPines Gas Exchange Monitor Starter KitMPSK10MPSK102019-03-25
00860001261509MediPines Gas Exchange MonitorAGM100AGM1002019-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521858077NellcorCovidien LPCCK2026-05-29
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10884521858091NellcorCovidien LPCCK2026-05-29
10884521858107NellcorCovidien LPCCK2026-05-29
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10612479282275McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14