GAMCATH TRAY MSGDHC1315JA

GUDID 55413765500263

The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies for insertion of the catheter.

BAXTER INTERNATIONAL INC.

Haemodialysis catheterization kit
Primary Device ID55413765500263
NIH Device Record Key178a1d76-d160-44ca-bb42-8fc3e4269690
Commercial Distribution StatusIn Commercial Distribution
Brand NameGAMCATH TRAY
Version Model NumberGAMHRVA10A
Catalog NumberMSGDHC1315JA
Company DUNS005146311
Company NameBAXTER INTERNATIONAL INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Device Dimensions

Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0
Length150 Millimeter
Catheter Gauge13 French
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105413765500268 [Primary]
GS155413765500263 [Package]
Contains: 05413765500268
Package: CASE [5 Units]
In Commercial Distribution

FDA Product Code

PEVDialysis administration kits (convenience kit)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-11-10

On-Brand Devices [GAMCATH TRAY]

55413765500294The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies f
55413765500287The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies f
55413765500270The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies f
55413765500263The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies f
55413765500256The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies f
55413765500249The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies f
55413765500232The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies f
55413765500225The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies f
55413765500218The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies f
55413765500201The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies f

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.