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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Arterial Line Kit 20ga x 3"
ARGON MEDICAL DEVICES, INC.
498411B
In Commercial Distribution

  • 20886333215656 ()
  • 00886333215652 ()

  • 20ga x 3"
498411B

  • Peripheral vascular catheter
Arterial Line Kit 20ga x 6"
ARGON MEDICAL DEVICES, INC.
498410B
In Commercial Distribution

  • 20886333215649 ()
  • 00886333215645 ()

  • 20ga x 6"
498410B

  • Peripheral vascular catheter
Arterial Line Kit 20ga x 6"
ARGON MEDICAL DEVICES, INC.
498406
Not in Commercial Distribution

  • 20886333215632 ()
  • 00886333215638 ()

  • 20ga x 6"
498406

  • Angiographic catheter, single-use
Arterial Line Kit 18ga x 6"
ARGON MEDICAL DEVICES, INC.
498112
Not in Commercial Distribution

  • 20886333215618 ()
  • 00886333215614 ()

  • 18ga x 6"
498112

  • Angiographic catheter, single-use
Contrast Injection Line 48" (122cm) M/F (PVC) 1000 PSI
ARGON MEDICAL DEVICES, INC.
197248
In Commercial Distribution

  • 20886333208672 ()
  • 00886333208678 ()

  • 48" (122cm), 1000 PSI
197248

  • Radiographic procedure tubing
Arterial Line Kit 20G x 6"
ARGON MEDICAL DEVICES, INC.
400115A
In Commercial Distribution

  • 20886333212884 ()
  • 00886333212880 ()

  • 20ga x 6"
400115A

  • Peripheral vascular catheter
No Description
Bien-Air Surgery SA
1502152
In Commercial Distribution

  • 27630055511007 ()
  • 17630055511000 ()
1502152-010

  • Suction/irrigation tubing, single-use
A 30 cc transducer connected with a 48" pressure tubing and a 3-Way White stopcock. It has a separately packed 2-xmale protective caps.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
687104
In Commercial Distribution

  • 50886333671040 ()
  • 00886333671045 ()

  • 30cc transducer
687104

  • Invasive-pressure external transducer, single-use
A single line 3cc transducer connected to a 20 drops, 60" tube Adset. The other end of the transducer is connected to a 12" pressure tubing via 3-way red stopcock.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
687102
In Commercial Distribution

  • 50886333671026 ()
  • 00886333671021 ()

  • 3cc DTX
687102

  • Invasive blood pressure monitoring tubing set
No Description
CHISON Medical Technologies Co., Ltd.
L10i-T
In Commercial Distribution

  • 06945121414272 ()
  • 06945121414418 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
CHISON Medical Technologies Co., Ltd.
L7R-T
In Commercial Distribution

  • 06945121414265 ()
  • 06945121414432 ()


  • Rectal/vaginal ultrasound imaging transducer
No Description
CHISON Medical Technologies Co., Ltd.
L18-T
In Commercial Distribution

  • 06945121414135 ()
  • 06945121414425 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
CHISON Medical Technologies Co., Ltd.
L12M-T
In Commercial Distribution

  • 06945121413527 ()
  • 06945121413541 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
TandemLife Priming Tray Accessory Kit
CARDIACASSIST, INC.
5180-0001
Not in Commercial Distribution

  • 00814112020500 ()


  • Mechanical infusion pump administration set
  • Cardiopulmonary bypass system mounting unit
30ml Burette Set w/ Stopcock & 60" Line
ARGON MEDICAL DEVICES, INC.
197653
Not in Commercial Distribution

  • 20886333208894 ()
  • 00886333208890 ()

  • 30ml Burette Set w/ 60" Line
197653

  • Fluid transfer set, general-purpose
ArgoTrans Keepsafe™ Macro, 6" & 9" Ext, 6' Line
ARGON MEDICAL DEVICES, INC.
041593505A
Not in Commercial Distribution

  • 20886333201826 ()
  • 00886333201822 ()

  • Macro 6" & 9" Ext. 6' Line
041593505A

  • Invasive blood pressure transducer set
ArgoTrans Keepsafe™ Macro, 6" & 9" Ext, 4' Line
ARGON MEDICAL DEVICES, INC.
041592505A
Not in Commercial Distribution

  • 20886333201819 ()
  • 00886333201815 ()

  • Macro 6" & 9" Ext, 4' Line
041592505A

  • Invasive blood pressure transducer set
Adult. O2/ETCO2 Filtered Nasal Divided Soft Cannula, 7' O2 line, 13' ETCO2 line
SALTER LABS
4MSF3SOFT-7-13
In Commercial Distribution

  • 30889483610996 ()
  • 10889483610992 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
Adult Nasal Cannula, 7' O2 Line, 2 inch CO2 Sampling Line w/Female Luer
WESTMED, INC.
08-0006
In Commercial Distribution

  • 10709078622431 ()
  • 00709078622434 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
CANNULA SOFT W/ 10' O2 LINE AND 10' CO2 LINE W/ MALE LUER-LOCK CONNECTOR
SALTER LABS
47SOFT-TG-14-14-25
In Commercial Distribution

  • 10607411946681 ()
47SOFT-TG-14-14-25

  • Nasal oxygen cannula, carbon-dioxide-sampling
Cannula, adult, divided w/7' O2 line & 2" CO2 line w/female luer-lock connector
SALTER LABS
SO-1180
In Commercial Distribution

  • 10607411302418 ()
  • 00607411302411 ()

  • Adult
SO-1180

  • Nasal oxygen cannula, carbon-dioxide-sampling
Disposable ECG monitoring lead line/shadowless line /AA type / 10-lead/clamp type /AHA/0.9M
Unimed Medical Supplies, Inc.
AAC10-90XDP
In Commercial Distribution

  • 06945664899437 ()


  • Electrocardiographic lead set, single-use
GENENTECH TRANSOFIX TRANS DEV
B. BRAUN MEDICAL INC.
7G0400
In Commercial Distribution

  • 04046964345388 ()
  • 04046964345364 ()
7G0400

  • Double-ended bag access spike
Transofix™ Transfer Spike
B. BRAUN MEDICAL INC.
415125
In Commercial Distribution

  • 04046963432782 ()
  • 04046963432775 ()
415125

  • Double-ended bag access spike
EYETEC Headband
NETWORK MEDICAL PRODUCTS LIMITED
40-950
In Commercial Distribution

  • 05060165012428 ()
  • 05056100703902 ()


  • Headband, single-use
ENDOVENT PULMONARY CATHETER KIT
Edwards Lifesciences LLC
EV
In Commercial Distribution

  • 00690103182866 ()

  • 8.3 FR. (2.8 MM) X 25.6" (65 CM)
EV

  • Chamber-decompression cardiac catheter
Vent Catheter
Edwards Lifesciences LLC
EM012
Not in Commercial Distribution

  • 00690103147469 ()
  • 50690103147464 ()

  • 12 Fr. (4.0 mm) x 35 cm (14")
EM012

  • Chamber-decompression cardiac catheter
Vent Catheter
Edwards Lifesciences LLC
E063
In Commercial Distribution

  • 00690103030907 ()
  • 50690103030902 ()

  • 20 Fr. (6.7 mm) x 36.8 cm (14.5")
E063

  • Chamber-decompression cardiac catheter
Vent Catheter
Edwards Lifesciences LLC
E061
In Commercial Distribution

  • 00690103030891 ()
  • 50690103030896 ()

  • 17 Fr. (5.7 mm) x 35 cm (14")
E061

  • Chamber-decompression cardiac catheter
Vent Catheter
Edwards Lifesciences LLC
E060
In Commercial Distribution

  • 00690103030884 ()
  • 50690103030889 ()

  • 17 Fr. (5.7 mm) x 35 cm (14")
E060

  • Chamber-decompression cardiac catheter
No Description
SORIN GROUP ITALIA SRL
W410-62
In Commercial Distribution

  • 38033178004511 ()
  • 08033178004510 ()


  • Chamber-decompression cardiac catheter
No Description
SORIN GROUP ITALIA SRL
W420-62
In Commercial Distribution

  • 38033178004504 ()
  • 08033178004503 ()


  • Chamber-decompression cardiac catheter
Headband for Navigation, single use
Karl Storz GmbH & Co. KG
40800083
In Commercial Distribution

  • 04048551279533 ()


  • Headband, single-use
Intended to be worn by operating room personnel during surgical procedures to absorb perspiration.
ASPEN SURGICAL PRODUCTS, INC.
400450
In Commercial Distribution

  • 00840113227358 ()
  • 00840113227341 ()


  • Headband, single-use
CUSTOM PACK 6J20R1 10PK MONIT LINE
MEDTRONIC, INC.
6J20R1
In Commercial Distribution

  • 20643169505432 ()
  • 00643169505438 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 8J41R 4PK ACCS LINE
MEDTRONIC, INC.
8J41R
In Commercial Distribution

  • 20643169502783 ()
  • 00643169502789 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 8J57R1 10PK OXYGEN LINE
MEDTRONIC, INC.
8J57R1
In Commercial Distribution

  • 20643169480982 ()
  • 00643169480988 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 9C64R 5PK BLOOD LINE
MEDTRONIC, INC.
9C64R
In Commercial Distribution

  • 20643169703012 ()
  • 00643169703001 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK TL8A52R1 2PK XTRA LINE
MEDTRONIC, INC.
TL8A52R1
In Commercial Distribution

  • 20643169428489 ()
  • 00643169428485 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 9182R4 5PK VENT LINE
MEDTRONIC, INC.
9182R4
In Commercial Distribution

  • 20643169052059 ()
  • 00643169052055 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB7C88R 20PK SPIKE LINE
MEDTRONIC, INC.
CB7C88R
In Commercial Distribution

  • 20643169034710 ()
  • 00643169034716 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 2806R3 10PK MONT LINE
MEDTRONIC, INC.
2806R3
In Commercial Distribution

  • 20643169068272 ()
  • 00643169068278 ()


  • Cardiopulmonary bypass system blood tubing set
GUIDEWIRE, 0.86MM W/ LASER LINE, SS
ARTHREX, INC.
AR-8737-21
In Commercial Distribution

  • 00888867046160 ()
  • 10888867046167 ()
AR-8737-21

  • Suturing unit, single-use
CUSTOM PACK 7H62R 10PK GILL LINE
MEDTRONIC, INC.
7H62R
In Commercial Distribution

  • 20643169117024 ()
  • 00643169117020 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB7R85R 8PK TABLE LINE
MEDTRONIC, INC.
CB7R85R
Not in Commercial Distribution

  • 20643169225682 ()
  • 00643169225688 ()


  • Cardiopulmonary bypass system blood tubing set
Specialty Drape Line Direct Anterior Hip
EXACT MEDICAL MANUFACTURING, INC.
ORI-SDL-DAHIP
Not in Commercial Distribution

  • 00850003355672 ()
  • 00850003355665 ()
ORI-SDL-DAHIP

  • Patient surgical drape, single-use
CENTRAL LINE DRSG CHG KIT MAC
Cardinal Health 200, LLC
03-0115I
In Commercial Distribution

  • 50888439899915 ()
  • 10888439899917 ()
03-0115I

  • General surgical procedure kit, medicated
CENTRAL LINE DRSG CHG KIT MAC
Cardinal Health 200, LLC
03-0115H
In Commercial Distribution

  • 50888439898765 ()
  • 10888439898767 ()
03-0115H

  • General surgical procedure kit, medicated
CENTRAL LINE DRSNG CHG PACK 2
Cardinal Health 200, LLC
03-7H9860D
In Commercial Distribution

  • 50888439984802 ()
  • 10888439984804 ()
03-7H9860D

  • General surgical procedure kit, medicated
LINE INSERT PORT A CATH PACK
MEDLINE INDUSTRIES, INC.
DYNJ51706C
In Commercial Distribution

  • 10193489538724 ()
  • 40193489538725 ()
DYNJ51706C

  • General surgical procedure kit, non-medicated, single-use
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