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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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Haemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems - 10812747011686

BMB PLS Bowls
HAEMONETICS CORPORATION
0625B-00
In Commercial Distribution

  • 30812747011680 ()
  • 10812747011686 ()

  • Total Volume: 275 Milliliter


  • Apheresis system tubing set

Typesafe - 10812269031285

Typesafe Segment Piercing Device
TYPENEX MEDICAL LLC
4R4750
In Commercial Distribution

  • 00812269031295 ()
  • 10812269031285 ()
  • 00812269031288 ()


  • Blood donor bag segment sampling IVD

Typesafe - 10812269031278

Typesafe Segment Piercing Device
TYPENEX MEDICAL LLC
TS500
In Commercial Distribution

  • 20812269031275 ()
  • 10812269031278 ()
  • 00812269031271 ()


  • Blood donor bag segment sampling IVD

Typesafe 2.0 - 10812269031254

Typesafe 2.0 - Quantity 1000
TYPENEX MEDICAL LLC
SP0201QM
In Commercial Distribution

  • 00812269031264 ()
  • 10812269031254 ()
  • 00812269031257 ()


  • Blood donor bag segment sampling IVD

Typesafe 2.0 - 10812269031230

Typesafe 2.0 - Quantity 500
TYPENEX MEDICAL LLC
SP0201QD
In Commercial Distribution

  • 00812269031240 ()
  • 10812269031230 ()
  • 00812269031233 ()


  • Blood donor bag segment sampling IVD

Haemonetics® PCS®2 & NexSys PCS® Systems - 10812747019347

PLS HARNESS SET
HAEMONETICS CORPORATION
00620-CC
In Commercial Distribution

  • 30812747019341 ()
  • 10812747019347 ()


  • Apheresis system tubing set

Haemonetics® PCS®2 & NexSys PCS® Systems - 10812747019279

PLS HARNESS SET
HAEMONETICS CORPORATION
00620-CP-CC
In Commercial Distribution

  • 30812747019273 ()
  • 10812747019279 ()


  • Apheresis system tubing set

S-Monovette® - 04038917228305

S-Monovette® 8.8 ml ACD-A
Sarstedt Aktiengesellschaft & Co.KG
01.1624.001
In Commercial Distribution

  • 04038917228299 ()
  • 04038917228305 ()
  • 04038917228312 ()
01.1624.001

  • Non-evacuated blood collection tube IVD, anticoagulant

Eurotrol - 08718734960409

Assayed Quality control solution
Eurotrol B.V.
188.003.002
In Commercial Distribution

  • 08718734960409 ()
  • 08718734960416 ()
188.003.002

  • Total haemoglobin (totHb) IVD, control

Eurotrol - 08718734960386

Assayed Quality control solution
Eurotrol B.V.
188.002.002
In Commercial Distribution

  • 08718734960386 ()
  • 08718734960393 ()
188.002.002

  • Total haemoglobin (totHb) IVD, control
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