GAMCATH TRAY MSGDHC1325A

GUDID 55413765500294

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 ID	55413765500294
NIH Device Record Key	beac6fe3-433e-4772-9396-052e65c0c5ee
Commercial Distribution Status	In Commercial Distribution
Brand Name	GAMCATH TRAY
Version Model Number	GAMHRVA05A
Catalog Number	MSGDHC1325A
Company DUNS	005146311
Company Name	BAXTER INTERNATIONAL INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	true
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0
Length	250 Millimeter
Catheter Gauge	13 French
Device Size Text, specify	0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05413765500299 [Primary]
GS1	55413765500294 [Package] Contains: 05413765500299 Package: CASE [5 Units] In Commercial Distribution

FDA Product Code

PEV	Dialysis administration kits (convenience kit)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2015-11-10

On-Brand Devices [GAMCATH TRAY]

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