FDA.reportPublic FDA data

Umbilical Catheter with Integral Low-Volume Closed Blood Sampling System

Primary DI
10865506000254
Brand
Umbilical Catheter with Integral Low-Volume Closed Blood Sampling System
Company
HUMMINGBIRD MED DEVICES INC
Model
UAC-HM-43P 4.3 fr. 32cm Polyurethane
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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSTSystem, Blood Collection, Vacuum-Assisted, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSTSystem, Blood Collection, Vacuum-Assisted, ManualHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10865506000254PackageGS15In Commercial Distribution
00865506000257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086550600025410865506000254
00865506000257008655060002578655060002570865506000257

GMDN Terms#

Term, Definition table
TermDefinition
Arterial blood sampling kitA collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080342917
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
00865506000233Umbilical Catheter with Integral Low-Volume Closed Blood Sampling SystemUAC-HM-35S 3.5 fr. 32cm Silicone2016-10-21
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
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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04719875918070Aeon Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-05-15
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06974481839128Needle HolderGuangzhou Improve Medical Instruments Co., Ltd.KST2025-03-14
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