FDA.reportPublic FDA data

NAMIC

Primary DI
H965907113620
Brand
NAMIC
Company
NAVILYST MEDICAL, INC.
Model
90711362
Device description
"PRESSURE MONITORING LINE 36"""
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRIMONITOR, LINE ISOLATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRIMonitor, Line IsolationCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H965907113621PackageHIBCC25In Commercial Distribution
H965907113620PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Invasive blood pressure monitoring tubing setA collection of devices that includes the necessary tubing and other items, e.g., connectors, stopcock(s), clamps and filters, used as an external connection for invasive blood pressure measurement. This set will interface, either directly or from an intermediate stopcock, between the applied invasive catheter and the measuring transducer. It will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length36Inch

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
809699023
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H787LG191005LifeguardLG-19-1002016-09-20
H787LG19755LifeguardLG-19-752016-09-20
H787LG201005LifeguardLG-20-1002016-09-20
H787LG201505LifeguardLG-20-1502016-09-20
H787LG20505LifeguardLG-20-502016-09-20
H787LG20755LifeguardLG-20-752016-09-20
H787LG221005LifeguardLG-22-1002016-09-20
H787LG22505LifeguardLG-22-502016-09-20
H787LG22755LifeguardLG-22-752016-09-20
H787LPS30045LifeportLPS 30042016-09-20
H787LPS30055LifeportLPS 30052016-09-20
H787LPS30065LifeportLPS 30062016-09-20
H787LPS30075LifeportLPS 30072016-09-20
H787LPS30085LifeportLPS 30082016-09-20
H787LPS30095LifeportLPS 30092016-09-20
H787LPS30175LifeportLPS 30172016-09-20
H787LPS30235LifeportLPS 30232016-09-20
H787LPS30255LifeportLPS 30252016-09-20
H787CT50LPBANFVI0BioFlo VortexCT50LPBANFVI2020-05-29
H787CT50LPBAVI0BioFlo VortexCT50LPBAVI2020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489068290NAMICMEDLINE INDUSTRIES, INC.DRI2023-12-21
10193489068306NAMICMEDLINE INDUSTRIES, INC.DRI2023-12-21
10193489068313NAMICMEDLINE INDUSTRIES, INC.DRI2023-12-21
10193489068320NAMICMEDLINE INDUSTRIES, INC.DRI2023-12-21
10193489068337NAMICMEDLINE INDUSTRIES, INC.DRI2023-12-21
10193489068344NAMICMEDLINE INDUSTRIES, INC.DRI2023-12-21
20193489068297NAMICMEDLINE INDUSTRIES, INC.DRI2023-12-21
20193489068303NAMICMEDLINE INDUSTRIES, INC.DRI2023-12-21
20193489068310NAMICMEDLINE INDUSTRIES, INC.DRI2023-12-21
20193489068327NAMICMEDLINE INDUSTRIES, INC.DRI2023-12-21
20193489068334NAMICMEDLINE INDUSTRIES, INC.DRI2023-12-21
20193489068341NAMICMEDLINE INDUSTRIES, INC.DRI2023-12-21
10197344015504MEDLINEMEDLINE INDUSTRIES, INC.DRI2023-09-18
20197344015501MEDLINEMEDLINE INDUSTRIES, INC.DRI2023-09-18
10193489257052Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DRI2022-08-04
10193489346060Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DRI2022-08-04
10193489631951Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DRI2022-08-04
10889942503865Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DRI2022-08-04
40193489067393NAMICMEDLINE INDUSTRIES, INC.DRI2022-08-04
40193489257053Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DRI2022-08-04
40193489346061Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DRI2022-08-04
40193489631952Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DRI2022-08-04
40889942503866Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DRI2022-08-04
20193489067399NAMICMEDLINE INDUSTRIES, INC.DRI2022-08-04
10193489268331Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DRI2021-11-08
40193489268332Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DRI2021-11-08
10193489068351NAMICMEDLINE INDUSTRIES, INC.DRI2021-07-26
10193489068368NAMICMEDLINE INDUSTRIES, INC.DRI2021-07-26
10193489068375NAMICMEDLINE INDUSTRIES, INC.DRI2021-07-26
10193489068382NAMICMEDLINE INDUSTRIES, INC.DRI2021-07-26