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 Class Implantable

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T-Cup with Vaccu Lid,3 SVT strips (CR/pH/S.G.) and Temp Strip
WONDFO USA CO., LTD.
TDOA-SVTV
In Commercial Distribution

  • 10816862024262 ()
  • 00816862024265 ()
  • 00816862024272 ()


  • General specimen container IVD, additive/medium
RTCII 1ST GEN THC/COC/METH/OPI300/AMP/BZO/ OXY/BAR/MTD/PCP/PPX/SVT
AMERICAN BIO MEDICA CORPORATION
10-11SPX2A-516
In Commercial Distribution

  • 10694644200482 ()
  • 10694644250487 ()
10-11SPX2A-516

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR,OX,SG)
Instant Technologies, Inc.
ABTDUAK15701A
In Commercial Distribution

  • 30817405023500 ()
  • 00817405023509 ()
  • 10817405023506 ()
ABTDUAK15701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 PANEL CLIA WAIVED SQUARE CUP AMP500, BZO300, COC150, MET500, MOP300 SVT (CR,pH,S.G.)
Instant Technologies, Inc.
ABTDUAW15702B
In Commercial Distribution

  • 30817405023395 ()
  • 00817405023394 ()
  • 10817405023391 ()
ABTDUAW15702B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 12 COC/THC/OPI300/AMP/MAMP/PCP/BZO/BAR/MTD/MDMA/OXY/BUP WITH SVT ???
REDWOOD TOXICOLOGY LABORATORY, INC.
011020188
In Commercial Distribution

  • 10858904006430 ()
  • 00858904006433 ()
DOA-1124-081

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 PANEL CLIA WAIVED SQUARE CUP AMP1000, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX,S.G.)
Instant Technologies, Inc.
ABTDUAW16701A
In Commercial Distribution

  • 30817405023258 ()
  • 00817405023257 ()
  • 10817405023254 ()
ABTDUAW16701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCUP Rx 5 Drug w/SVT (pH, SG, OX, CR,NI) (BZO300/BUP10/MTD300/OPI300/OXY100)
Instant Technologies, Inc.
I-RXA-157-01
In Commercial Distribution

  • 00817405020270 ()
I-RXA-157-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Datascope Trio Compatible Oximax Direct Connect Ear Clip Sensor
APK Technology Co.,Ltd.
10306
In Commercial Distribution

  • 06946725554357 ()


  • Tissue saturation oximeter sensor, reprocessed
Compatible with GE, 3 Lead Grouped ECG lead wires,Pinch,AHA
APK Technology Co.,Ltd.
A3157-EL1-001
In Commercial Distribution

  • 06946725538869 ()


  • Electrocardiographic lead set, reusable
GE Apex Pro FH-Philips 5L ECG Adapter
APK Technology Co.,Ltd.
A-CO-190
In Commercial Distribution

  • 16946725590789 ()
  • 06946725529942 ()
  • 16946725590956 ()


  • Electrocardiographic lead set, reusable
Temperature Adaptter Cable
APK Technology Co.,Ltd.
DHP-30-AD0
Not in Commercial Distribution

  • 06946725529072 ()


  • Electrocardiographic lead set, reusable
Mindray Bene/Pass-Philips 5L ECG Adapter
APK Technology Co.,Ltd.
A-CO-183
In Commercial Distribution

  • 06946725529041 ()
  • 16946725590642 ()
  • 16946725590925 ()


  • Electrocardiographic lead set, reusable
Mindray Pano-Philips 3L ECG Adapter
APK Technology Co.,Ltd.
A-CO-182
In Commercial Distribution

  • 06946725529034 ()
  • 16946725590635 ()
  • 16946725590918 ()


  • Electrocardiographic lead set, reusable
Spacelabs Ultra-Philips 5L ECG Adapter
APK Technology Co.,Ltd.
A-CO-181
In Commercial Distribution

  • 06946725529027 ()
  • 16946725590628 ()
  • 16946725590901 ()


  • Electrocardiographic lead set, reusable
Spacelabs Ultra-Philips 3L ECG Adapter
APK Technology Co.,Ltd.
A-CO-180
In Commercial Distribution

  • 06946725529010 ()
  • 16946725590611 ()
  • 16946725590895 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
MDR-009-004782-00
In Commercial Distribution

  • 06946725528686 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
MDR-009-004786-00
In Commercial Distribution

  • 06946725528679 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
PH-989803171851
In Commercial Distribution

  • 06946725528648 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
MDR-009-004782-00-DP
In Commercial Distribution

  • 06946725528631 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
MDR-009-004786-00-DP
In Commercial Distribution

  • 06946725528624 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
MDR-009-004782-00
In Commercial Distribution

  • 06946725528617 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
MDR-009-004786-00
In Commercial Distribution

  • 06946725528600 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
A1902-TC01
In Commercial Distribution

  • 06946725528570 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
NK-BR-906PA-DP
In Commercial Distribution

  • 06946725528556 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
NK-BR-916PA-DP
In Commercial Distribution

  • 06946725528549 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
DLS-DIN-24
In Commercial Distribution

  • 06946725528273 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
NK-BR-913PA-DP
In Commercial Distribution

  • 06946725528266 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
10352
In Commercial Distribution

  • 06946725528105 ()


  • Electrocardiographic lead set, reusable
6946725527993
APK Technology Co.,Ltd.
A1902-C02
In Commercial Distribution

  • 06946725527993 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
A0006D05-001
In Commercial Distribution

  • 06946725527306 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
A0006D05
In Commercial Distribution

  • 06946725527290 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
A0006D03-001
In Commercial Distribution

  • 06946725527283 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
A0006D03
In Commercial Distribution

  • 06946725527276 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
A0005D06-001
In Commercial Distribution

  • 06946725527269 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
A0005D06
In Commercial Distribution

  • 06946725527252 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
A0005D05-001
In Commercial Distribution

  • 06946725527245 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
A0005D05
In Commercial Distribution

  • 06946725527238 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
A0005D03-001
In Commercial Distribution

  • 06946725527221 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
A0005D03
In Commercial Distribution

  • 06946725527214 ()


  • Electrocardiographic lead set, reusable
No Description
APK Technology Co.,Ltd.
A0004D06-001
In Commercial Distribution

  • 06946725527207 ()


  • Electrocardiographic lead set, reusable
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