FDA.reportPublic FDA data

Umbilical Catheter with Integral Low-Volume Closed Blood Sampling System

Primary DI
00865506000233
Brand
Umbilical Catheter with Integral Low-Volume Closed Blood Sampling System
Company
HUMMINGBIRD MED DEVICES INC
Model
UAC-HM-35S 3.5 fr. 32cm Silicone
Device description
Single Lumen, sterile, radiopaque catheter with radius tip, Hummi Micro-Draw Blood transfer Device, Micro T Split Septum T-Connector, Dual Port Device with two closed-port silicone valve
Published
2016-10-21
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
FMGStopcock, I.V. Set
FOSCatheter, Umbilical Artery
FPASet, Administration, Intravascular
KSTSystem, Blood Collection, Vacuum-Assisted, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMGStopcock, I.V. SetGeneral Hospital2
FOSCatheter, Umbilical ArteryGeneral Hospital2
FPASet, Administration, IntravascularGeneral Hospital2
KSTSystem, Blood Collection, Vacuum-Assisted, ManualHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10865506000230PackageGS15In Commercial Distribution
00865506000233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086550600023010865506000230
00865506000233008655060002338655060002330865506000233

GMDN Terms#

Term, Definition table
TermDefinition
Split-septum needleless valve-connectorA small, sterile, stand-alone, needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position, and through which IV access is gained via blunt cannula separation of a septum. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
949-215-6453solson@hummingbirdmed.com

Regulatory Flags#

DUNS number
080342917
Device count
1
Kit
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
00850584007007Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-35P2 3.5 fr. 32cm Polyurethane2018-01-19
00850584007021Dual Port Device with two integral silicone valvesDPD-HM-22016-10-21
00850584007045Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-50P2 5.0 fr. 32cm Polyurethane2018-01-19
00865506000226Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-25P 2.5 fr. 25cm Polyurethane2016-10-21
00865506000257Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-43P 4.3 fr. 32cm Polyurethane2016-10-21
00865506000264Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-50S 5.0 fr. 32cm Silicone2016-10-21
00865506000271Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-50P 5.0 fr. 32cm Polyurethane2016-10-21
00865506000288Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-35P 3.5 fr. 32cm Polyurethane2016-10-21
10850584007004Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-35P2 3.5 fr. 32cm Polyurethane2018-01-19
00850584007014Split Septum Micro T-ConnectorNMT80462016-09-16
10850584007028Dual Port Device with two integral silicone valvesDPD-HM-22016-10-21
10850584007042Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-50P2 5.0 fr. 32cm Polyurethane2018-01-19
10865506000223Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-25P 2.5 fr. 25cm Polyurethane2016-10-21
10865506000230Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-35S 3.5 fr. 32cm Silicone2016-10-21
10865506000254Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-43P 4.3 fr. 32cm Polyurethane2016-10-21
10865506000261Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-50S 5.0 fr. 32cm Silicone2016-10-21
10865506000278Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-50P 5.0 fr. 32cm Polyurethane2016-10-21
10865506000285Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-35P 3.5 fr. 32cm Polyurethane2016-10-21

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