FDA.reportPublic FDA data

Microstream Luer

Primary DI
20884521762197
Brand
Microstream Luer
Company
Covidien LP
Model
010555
Device description
Male to Male Adaptor
Published
2023-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAICircuit, breathing (w connector, adaptor, y piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521762190PrimaryGS10
20884521762197Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452176219010884521762190
2088452176219720884521762197

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521072602V-LocVLOCN204L2015-09-02
20884521126852Sofsilk1700022016-09-24
10884521091986NellcorSC-A-I2026-05-25
10884521758803Vascufil8886470311V-22020-07-19
10884521816312McGRATH MAC350-005-0002021-10-21
10884521816329McGRATH MAC350-013-0002021-08-30
10884521816336McGRATH MAC350-017-0002021-10-18
10884521816343McGRATH MAC350-072-0002022-06-13
10884521824317McGRATH MAC350-005-0002022-09-25
10884521824324McGRATH MAC350-013-0002021-10-30
10884521824331McGRATH MAC350-017-0002021-08-26
10884521824348McGRATH MAC350-072-0002023-06-19
10884521850118McGRATH MAC350-005-0002025-04-27
10884521850125McGRATH MAC350-013-0002025-04-27
10884521850132McGRATH MAC350-017-0002025-04-27
10884521850149McGRATH MAC350-072-0002025-04-27
15060272980310McGRATH MAC350-005-0002021-08-02
15060272980327McGRATH MAC350-013-0002022-01-17
15060272980334McGRATH MAC350-072-0002021-04-18
15060272980341McGRATH MAC350-017-0002021-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08697645010048Standard Breathing Circuit with Face Mask - ToddlerMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010079Standard Breathing Circuit with MouthpieceMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010116Standard Breathing Circuit with Face Mask - Adult MediumMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010550Standard Breathing Circuit with TrachMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
H66860701051Mizzy Comfort CushionKeystone IndustriesCAI2022-11-30
H66860701151Mizzy Comfort CushionKeystone IndustriesCAI2022-11-30
10080196082070Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983599Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983933Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983940Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983971Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196984176Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2021-11-03
10080196984343Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2021-11-03
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10190752108820Vital Signs™VYAIRE MEDICAL, INC.CAI2021-07-06
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10190752118904Vital Signs™AIRLIFECAI2020-02-20
10190752118911Vital Signs™AIRLIFECAI2020-02-20
10190752118928Vital Signs™AIRLIFECAI2020-02-20
10190752118942Vital Signs™AIRLIFECAI2020-02-20
10190752118997Vital Signs™VYAIRE MEDICAL, INC.CAI2020-02-20