Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Y-Type Spike Adapter
BAXTER INTERNATIONAL INC.
1C8433
In Commercial Distribution

  • 50085412014048 ()
  • 00085412014043 ()
1C8433

  • Basic intravenous administration set, noninvasive
Y-Type Blood/Solution Set with Standard Blood Filter, 170 to 260 Micron Filter, 2 Injection Sites, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
1C8372
In Commercial Distribution

  • 50085412013775 ()
  • 00085412013770 ()
1C8372

  • Blood transfusion set, non-exchange
Extension Set, 0.2 Micron Downstream Filter, Polyethylene Lined Tubing, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
1C8363
In Commercial Distribution

  • 50085412013713 ()
  • 00085412013718 ()
1C8363

  • Intravenous administration tubing extension set
Blood Bag Spike, Injection Site
BAXTER INTERNATIONAL INC.
1C8333
In Commercial Distribution

  • 50085412013614 ()
  • 00085412013619 ()
1C8333

  • Blood transfusion set, non-exchange
Subcutaneous Infusion Set
BAXTER HEALTHCARE CORPORATION
1M8463
In Commercial Distribution

  • 50085412013485 ()
  • 00085412013480 ()
1M8463

  • Subcutaneous infusion/injection port needle
0.2% Dextrose and 0.9% Sodium Chloride Processing Solution, 2000 mL
BAXTER HEALTHCARE CORPORATION
4B7878
In Commercial Distribution

  • 50085412010743 ()
  • 00085412010748 ()
4B7878

  • Blood cell freeze/thaw system
12% Sodium Chloride Processing Solution, 150 mL
BAXTER HEALTHCARE CORPORATION
4B7874Q
In Commercial Distribution

  • 50085412010729 ()
  • 00085412010724 ()
4B7874Q

  • Blood cell freeze/thaw system
1.6% Sodium Chloride Processing Solution, 2000 mL
BAXTER HEALTHCARE CORPORATION
4B7871
In Commercial Distribution

  • 50085412010712 ()
  • 00085412010717 ()
4B7871

  • Blood cell freeze/thaw system
This set is designed to allow drainage of peritoneal dialysis effluent from the drain line on an automated peritoneal dialysis cycler tubing set into 2 drain bags.
BAXTER INTERNATIONAL INC.
5C4512
In Commercial Distribution

  • 50085412007750 ()
  • 00085412007755 ()
5C4512

  • Peritoneal dialysis system tubing set
This set consists of a female locking connector/on-0ff clamp assembly, tubing and double sealing male Luer lock connector. This set it to be used with Baxter Locking Titanium Adapter for Peritoneal Dialysis Catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.
BAXTER HEALTHCARE CORPORATION
5C4483
In Commercial Distribution

  • 50085412007743 ()
  • 00085412007748 ()
5C4483

  • Peritoneal dialysis system tubing set
This set consists of a female locking connector/on-off clamp assembly, tubing and double sealing male Luer lock connector. This set is to be used with the Baxter Locking Titanium Adapter for Peritoneal Dialysis Catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.
BAXTER HEALTHCARE CORPORATION
5C4482
In Commercial Distribution

  • 50085412007736 ()
  • 00085412007731 ()
5C4482

  • Peritoneal dialysis system tubing set
This bag is intended to collect sample drainage of peritoneal dialysis effluent from Baxter Peritoneal Dialysis Tubing Sets and is intended for use with Luer connector products.
BAXTER INTERNATIONAL INC.
5C4476
In Commercial Distribution

  • 50085412007712 ()
  • 00085412007717 ()
5C4476

  • Peritoneal dialysis system tubing set
This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.
BAXTER HEALTHCARE CORPORATION
5C4466P
In Commercial Distribution

  • 50085412007699 ()
  • 00085412007694 ()
5C4466P

  • Peritoneal dialysis system tubing set
This set is intended for use with a Baxter transfer set for peritoneal dialysis patients requiring a sterile container for drainage. (i.e. CCPD patients doing a daytime exchange or CAPD patients who have disconnected between exchanges).
BAXTER INTERNATIONAL INC.
5C4462
In Commercial Distribution

  • 50085412007675 ()
  • 00085412007670 ()

  • Total Volume: 3 Liter
5C4462

  • Peritoneal dialysis system tubing set
This device is a double sealing male Luer lock intended for use with the Baxter Locking Titanium Adapter for Peritoneal Dialysis.
BAXTER INTERNATIONAL INC.
5C4169
In Commercial Distribution

  • 50085412007439 ()
  • 00085412007434 ()
5C4169

  • Peritoneal dialysis catheter adaptor, single-use
This adapter is a double sealing female Luer lock adapter with a 2-piece, combination compression fit/barbed catheter connector. The adapter is used to connect the PD catheter to a solution transfer set with locking connector.
BAXTER INTERNATIONAL INC.
5C4129
In Commercial Distribution

  • 50085412007408 ()
  • 00085412007403 ()
5C4129

  • Peritoneal dialysis catheter adaptor, single-use
Premixed Dialysate for Hemodiafiltration is indicated for acute dialysis modalities that employ hemodiafiltration, such as continuous arteriovenous hemodiafiltration (CAVHD) and Continuous Venous-Venous Hemodiafiltration (CVVHD), when treatment of acute renal failure patients with hypervolemia and uremia requires high solute clearance.
BAXTER INTERNATIONAL INC.
5B7860
Not in Commercial Distribution

  • 50085412007385 ()
  • 00085412007380 ()

  • Total Volume: 5000 Milliliter
5B7860

  • Haemodialysis concentrate
The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
BAXTER INTERNATIONAL INC.
5C4471R
In Commercial Distribution

  • 00085412007038 ()
5C4471R

  • Peritoneal dialysis system
The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
BAXTER INTERNATIONAL INC.
5C4471
In Commercial Distribution

  • 00085412007021 ()
5C4471

  • Peritoneal dialysis system
Injection Site
BAXTER INTERNATIONAL INC.
2N3399
In Commercial Distribution

  • 50085412004988 ()
  • 00085412004983 ()
2N3399

  • Catheter injection port
Universal Vial Adapter
BAXTER INTERNATIONAL INC.
2N3395
In Commercial Distribution

  • 50085412004971 ()
  • 20085412004970 ()
  • 00085412004976 ()
2N3395

  • Vial/bottle adaptor, hermetic
Injection Site
BAXTER INTERNATIONAL INC.
2N3379
In Commercial Distribution

  • 50085412004940 ()
  • 20085412004949 ()
  • 00085412004945 ()
2N3379

  • Catheter injection port
Non-DEHP Catheter Extension Set, Injection Site, Male Luer Lock Adapter with Retractable Collar
BAXTER INTERNATIONAL INC.
2N3378
In Commercial Distribution

  • 50085412004933 ()
  • 00085412004938 ()
2N3378

  • Intravenous administration tubing extension set
Non-DEHP Y-Type Catheter Extension Set, 2 Injection Sites, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2N3376
In Commercial Distribution

  • 20085412004925 ()
  • 00085412004921 ()
  • 50085412004926 ()
2N3376

  • Intravenous administration tubing extension set
Non-DEHP Catheter Extension Set, Injection Site, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2N3375
In Commercial Distribution

  • 50085412004919 ()
  • 00085412004914 ()
2N3375

  • Intravenous administration tubing extension set
Non-DEHP Catheter Extension Set, Injection Site, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2N3374
In Commercial Distribution

  • 50085412004902 ()
  • 00085412004907 ()
2N3374

  • Intravenous administration tubing extension set
Non-DEHP I.V. Connector Loop, Injection Site, Male Luer Lock with Rotating Collar
BAXTER INTERNATIONAL INC.
2N3373
In Commercial Distribution

  • 50085412004896 ()
  • 00085412004891 ()
2N3373

  • Basic intravenous administration set, noninvasive
Non-DEHP Y-Type Catheter Extension Set, 2 Injection Sites, Male Luer Lock Adapter
BAXTER HEALTHCARE CORPORATION
2N3371
In Commercial Distribution

  • 50085412004872 ()
  • 00085412004877 ()
2N3371

  • Intravenous administration tubing extension set
Non-DEHP MICRO-VOLUME Extension Set, 0.2 Micron Downstream Filter, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2N3350
In Commercial Distribution

  • 50085412004841 ()
  • 00085412004846 ()
2N3350

  • Intravenous line filter
Non-DEHP High Flow Rate Extension Set, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2N3349
In Commercial Distribution

  • 50085412004834 ()
  • 00085412004839 ()
2N3349

  • Intravenous administration tubing extension set
Non-DEHP MICRO-VOLUME Extension Set, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2N3348
In Commercial Distribution

  • 50085412004827 ()
  • 00085412004822 ()
2N3348

  • Intravenous administration tubing extension set
Non-DEHP MICRO-VOLUME Extension Set, 0.2 Micron Downstream Filter, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2N3347
In Commercial Distribution

  • 50085412004810 ()
  • 00085412004815 ()
2N3347

  • Intravenous line filter
Non-DEHP High Flow Rate Extension Set, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2N3346
In Commercial Distribution

  • 50085412004803 ()
  • 00085412004808 ()
2N3346

  • Intravenous administration tubing extension set
Non-DEHP MICRO-VOLUME Extension Set, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2N3345
In Commercial Distribution

  • 50085412004797 ()
  • 00085412004792 ()
2N3345

  • Intravenous administration tubing extension set
Non-DEHP T-Connector Extension Set, T Housing, Retractable T-Connector, Injection Site
BAXTER INTERNATIONAL INC.
2N3343
In Commercial Distribution

  • 50085412004780 ()
  • 00085412004785 ()
2N3343

  • Intravenous administration tubing extension set
Non-DEHP Three Lead Catheter Extension Set, 0.2 Micron Filter, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2N3342
In Commercial Distribution

  • 50085412004773 ()
  • 00085412004778 ()
2N3342

  • Intravenous administration tubing extension set
Non-DEHP Three Lead Extension Set, Injection Site, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2N3341
In Commercial Distribution

  • 20085412004765 ()
  • 00085412004761 ()
  • 50085412004766 ()
2N3341

  • Intravenous administration tubing extension set
Non-DEHP T-Connector Extension Set, T housing, Retractable T-Connector
BAXTER INTERNATIONAL INC.
2N3340
In Commercial Distribution

  • 50085412004759 ()
  • 00085412004754 ()
2N3340

  • Intravenous administration tubing extension set
Non-DEHP T-Connector Extension Set, T Housing, Retractable T-Connector
BAXTER INTERNATIONAL INC.
2N3339
In Commercial Distribution

  • 50085412004742 ()
  • 00085412004747 ()
2N3339

  • Intravenous administration tubing extension set
Non-DEHP T-Connector Catheter Extension Set, T-Housing, 0.2 Micron Filter, Rotating T-Connector
BAXTER INTERNATIONAL INC.
2N3333
In Commercial Distribution

  • 50085412004711 ()
  • 20085412004710 ()
  • 00085412004716 ()
2N3333

  • Intravenous administration tubing extension set
Non-DEHP T-Connector Extension Set, T Housing, Rotating T-Connector
BAXTER INTERNATIONAL INC.
2N3328
In Commercial Distribution

  • 50085412004667 ()
  • 00085412004662 ()
2N3328

  • Intravenous administration tubing extension set
Non-DEHP T-Connector Extension Set, T Housing, Rotating T-Connector
BAXTER INTERNATIONAL INC.
2N3327
In Commercial Distribution

  • 50085412004650 ()
  • 00085412004655 ()
2N3327

  • Intravenous administration tubing extension set
Non-DEHP T-Connector Extension Set, T Housing, Male Luer Slip T-Connector
BAXTER INTERNATIONAL INC.
2N3326
In Commercial Distribution

  • 50085412004643 ()
  • 00085412004648 ()
2N3326

  • Intravenous administration tubing extension set
Non-DEHP Catheter Extension Set, Male Luer Lock Adapter with Retractable Collar
BAXTER INTERNATIONAL INC.
2N1206
In Commercial Distribution

  • 50085412004612 ()
  • 00085412004617 ()
2N1206

  • Intravenous administration tubing extension set
Non-DEHP Y-Type Catheter Extension Set, Male Luer Lock Adapter
BAXTER HEALTHCARE CORPORATION
2N1191
In Commercial Distribution

  • 50085412004537 ()
  • 00085412004532 ()
2N1191

  • Intravenous administration tubing extension set
Lever Lock Cannula with Check Valve
BAXTER INTERNATIONAL INC.
2C9292
In Commercial Distribution

  • 50085412004353 ()
  • 00085412004358 ()
2C9292

  • Intravenous line recessed-needle connector
Universal Anesthesia Set, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2C9218
In Commercial Distribution

  • 50085412004254 ()
  • 00085412004259 ()
2C9218

  • Basic intravenous administration set, noninvasive
Anesthesia Set, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2C9216
In Commercial Distribution

  • 50085412004230 ()
  • 00085412004235 ()
2C9216

  • Basic intravenous administration set, noninvasive
Microbore Extension Set, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2C9203
In Commercial Distribution

  • 50085412004193 ()
  • 00085412004198 ()
2C9203

  • Intravenous administration tubing extension set
Microbore Extension Set, Male Luer Lock Adapter
BAXTER INTERNATIONAL INC.
2C9201
In Commercial Distribution

  • 50085412004179 ()
  • 00085412004174 ()
2C9201

  • Intravenous administration tubing extension set
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