R5C4479

GUDID 50085412030536

Peritoneal dialysis system tubing set

Primary Device ID	50085412030536
NIH Device Record Key	2ac9c4f5-06d4-4415-a830-1bb010b6fcf8
Commercial Distribution Status	In Commercial Distribution
Version Model Number	R5C4479
Catalog Number	R5C4479
Company DUNS	481009905
Company Name	Baxter Healthcare SA
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
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	true
RX Perscription	false
OTC Over-The-Counter	false

Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature

Device Issuing Agency	Device ID
GS1	00085412030531 [Primary]
GS1	50085412030536 [Package] Contains: 00085412030531 Package: CA [30 Units] In Commercial Distribution

FKX	System, peritoneal, automatic delivery

Steralize Prior To Use	false
Device Is Sterile	false

50085412030536 - NA	2025-09-05HomeChoice Automated PD Set with Cassette and 4-Prong Luers
50085412030536 - NA	2025-09-05 HomeChoice Automated PD Set with Cassette and 4-Prong Luers
50085412169281 - DUO-VENT	2025-03-28 Solution Transfer Set with DUO-VENT Spike. Large Bore Tubing and Needle Adapter 26”
50085412908392 - Revaclear	2024-04-22 Revaclear 500 dialyzer is indicated for the treatment of chronic or acute renal failure.
50085412908422 - Revaclear	2024-04-22 Revaclear 400 dialyzer is indicated for the treatment of chronic or acute renal failure.
50085412908439 - Revaclear	2024-04-22 Revaclear 300 dialyzer is indicated for the treatment of chronic or acute renal failure.