DEVICE: GamCath HighFlow Dolphin Catheter (07332414110666)
Device Identifier (DI) Information
GamCath HighFlow Dolphin Catheter
GAMCATH MS-GDHC-1115 A
In Commercial Distribution
114022
Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
GAMCATH MS-GDHC-1115 A
In Commercial Distribution
114022
Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
Short-term use to obtain vasular access in patients with acute or chronic renal failure. The GamCath HighFlow Dolphin Catheter combines the GamCath HighFlow Catheter with an additional coating based on a block copolymer.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Double-lumen haemodialysis catheter, nonimplantable | A sterile, flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access, primarily 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 is intended for coaxial flow of blood and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MPB | CATHETER, HEMODIALYSIS, NON-IMPLANTED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K100451 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep dry. Keep away from sunlight. |
Storage Environment Temperature: less than 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Length: 150 Millimeter |
Catheter Gauge: 11.5 French |
Device Size Text, specify: STRAIGHT |
Device Record Status
afe0600b-0d2a-4a87-8cb5-50441862c7cf
July 06, 2018
3
October 07, 2015
July 06, 2018
3
October 07, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
37332414110667 | 5 | 07332414110666 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
Medinfo_medproducts@baxter.com