DEVICE: NA (07332414010867)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KOC | ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K823707 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 32 and 86 Degrees Fahrenheit |
Special Storage Condition, Specify: Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit |
Special Storage Condition, Specify: Must be stored in a dry place. Keep dry |
Storage Environment Temperature: between 0 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
00beb62a-2520-4345-acf2-c637f4e27b8e
July 06, 2018
3
October 28, 2016
July 06, 2018
3
October 28, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
37332414010868 | 75 | 07332414010867 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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