FDA.reportPublic FDA data

GAMCATH TRAY

Primary DI
55413765500218
Brand
GAMCATH TRAY
Company
BAXTER INTERNATIONAL INC.
Model
GAMHRVA03A
Catalog number
MSGDHC1115A
Device description
The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies for insertion of the catheter.
Published
2015-11-10
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
PEVDialysis administration kits (convenience kit)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEVDialysis Administration KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
55413765500218PackageGS15In Commercial Distribution
05413765500213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5541376550021855413765500218
05413765500213054137655002135413765500213

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis catheterization kitA collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It includes a nonimplantable double-lumen haemodialysis catheter, device dedicated to catheter introduction/function (e.g., introducer needle, guidewire) and includes non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge11.5French
Device Size Text, specify0
Length150Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
005146311
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412088303V-LINK/VITALSHIELD6N83996N83992016-09-24
00085412091785ONE-LINK7N83997N83992016-09-24
00085412087672LOW RECIRCULATION VOLUME APD SETN5C8305CN5C8305C2015-09-24
00085412088433AUTOMATED PD SETR5C4479CR5C4479C2015-09-24
00085412090078INTERGRATED APD SETL5C4531L5C45312015-09-24
00085412007021HomeChoice APD System5C44715C44712015-10-23
00085412007038HomeChoice APD System5C4471R5C4471R2015-10-23
00085412026350HomeChoice PRO APD System5C8310R5C8310R2015-10-23
00085412079165HomeChoice PRO APD System5C83105C83102015-10-23
00085412088341V-LINK/VITALSHIELD6N83786N83782016-09-24
00085412088327V-LINK/VITALSHIELD6N83746N83742016-09-24
00085412001036NA2C40312C40312016-09-24
00085412004716INTERLINK2N33332N33332016-09-24
00085412004921INTERLINK2N33762N33762016-09-24
00085412004976INTERLINK2N33952N33952016-09-24
00085412071657CLEARLINK2N83412N83412016-09-24
00085412001029NA2C40302C40302016-09-24
05413760308371Fibrinotherm060004706000472018-09-21
00085412003252N/A2B80662B80662016-09-24
00085412000046INTRAVIA2B80142B80142016-09-24

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Primary DI, Brand, Company table
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