DEVICE: Recirculation Adapter/Priming Connector (07332414055189)

Device Identifier (DI) Information

Recirculation Adapter/Priming Connector
106283
In Commercial Distribution
106283
Gambro Renal Products, S.A. de C.V.
07332414055189
GS1

1
812560399 *Terms of Use
This blood tubing set accessory is intended for single use in a hemodialysis treatment. It may be used either as a recirculation adapter during use to connect the arterial and venous patient together or as a means to connect the blood tubing set to the Waste Handling Option (WHO) on Phoenix machines during prime.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Haemodialysis tubing set, single-use A collection of sterile items intended for the administration of haemodialysis. It will typically consist of a collection of tubing segments and, e.g., connectors or clamps, required to transport blood or other fluids from a patient's vascular access device to the appropriate dialyser (haemodialyser) unit for processing. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FJK SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 0 and 120 Degrees Fahrenheit
Special Storage Condition, Specify: The accessory system must be stored in a dry place
Storage Environment Temperature: between -18 and 49 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

d1105f7a-c208-408f-8107-19e51ce4d1e1
March 29, 2018
2
October 23, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
37332414055180 100 07332414055189 In Commercial Distribution CASE
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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