EASYGRIP FLO-41 ADS201897

GUDID 55413765586113

The EASYGRIP FLO-41 Precision MIS Delivery System (EASYGRIP FLO-41 System) is a sterile, single-use device that consists of two components: (1) one applicator device with a 41 cm long cannula (5 mm outer diameter) and (2) one empty 1.5 mL syringe.

BAXTER HEALTHCARE CORPORATION

Haematological concentrate applicator
Primary Device ID55413765586113
NIH Device Record Key51a80c6a-390c-4bb1-affd-7de4c2d5b4b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameEASYGRIP FLO-41
Version Model NumberADS201897
Catalog NumberADS201897
Company DUNS005083209
Company NameBAXTER HEALTHCARE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com

Device Dimensions

Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter
Length41 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105413765586118 [Primary]
GS155413765586113 [Package]
Contains: 05413765586118
Package: CASE [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-16
Device Publish Date2020-04-08

Devices Manufactured by BAXTER HEALTHCARE CORPORATION

05413765852428 - Novum IQ2024-09-23 The Novum IQ Syringe Pump is software controlled Syringe infusion pump system that provides delivery of fluids into a patient
20085412676610 - DOSE IQ SAFETY SOFTWARE2024-09-02 Infusion Safety Management Software
20085412841629 - MINICAP EXTENDED LIFE PD TRNS2024-08-13 This set consists of a female locking connector/on-off clamp assembly, tubing and double sealing male Luer lock connector. This
50197886004354 - CLEARLINK/CONTINU-FLO2024-06-10 QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 1
50197886004361 - CLEARLINK/CONTINU-FLO2024-06-10 QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 9
10085412676613 - DOSE IQ SAFETY SOFTWARE2024-04-30 Infusion Safety Management Software
05413765851797 - Novum IQ2024-04-18 The Novum IQ Large Volume Pump (LVP) is a large volume infusion pump system that provides delivery of fluids into a patient in a
51978860004350 - CLEARLINK/CONTINU-FLO2024-04-04 QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 1

Trademark Results [EASYGRIP FLO-41]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EASYGRIP FLO-41
EASYGRIP FLO-41
88181951 not registered Live/Pending
Baxter International Inc.
2018-11-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.