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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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DreamStation BiPAP Pro with Humidifier, with Heated Tube, International
Respironics, Inc.
DreamStation BiPAP Pro w/Humidi w/H Tube, INTL
In Commercial Distribution

  • 00606959025929 ()
INX600T15

  • Home BPAP unit
DreamStation CPAP Pro with Humidifier, with Heated Tube, International
Respironics, Inc.
DreamStation CPAP Pro w/Humid w/H Tube, INTL
In Commercial Distribution

  • 00606959025868 ()
INX400T15

  • Home CPAP unit
DreamStation CPAP Pro with C Flex with Humidifier, GB
Respironics, Inc.
DreamStation CPAP Pro with C Flex with Humidifier, GB
In Commercial Distribution

  • 00606959043824 ()
GBX401H15

  • Home CPAP unit
DreamStation BiPAP autoSV with Humidifier, with Heated Tube, Canada
Respironics, Inc.
DreamStation BiPAP autoSV w/Humid w/H Tube, CA
In Commercial Distribution

  • 00606959040564 ()
CAX900T12

  • Portable electric ventilator
DreamStation BiPAP autoSV with Humidifier, with Heated Tube, USA
Respironics, Inc.
DreamStation BiPAP autoSV w/Humidr w/H Tube, US
In Commercial Distribution

  • 00606959040533 ()
DSX900T11

  • Portable electric ventilator
Wisp Mask, with Fabric Frame, with Headgear, Large, International
Respironics, Inc.
Wisp Mask, Large, Fabric Frame, with Headgear, INTL
In Commercial Distribution

  • 00606959040076 ()
1094049

  • CPAP/BPAP nasal mask, reusable
Wisp Mask, with Clear Frame, with Headgear, Small-Medium, International
Respironics, Inc.
Wisp Mask, Small-Medium, Clear Frame, w/Headgear, INTL
In Commercial Distribution

  • 00606959040021 ()
1093924

  • CPAP/BPAP nasal mask, reusable
REMstar SE Auto with Humidifier, with SD Slot, Domestic
Respironics, Inc.
00
In Commercial Distribution

  • 00606959037083 ()
DS520HS

  • Home CPAP unit
  • Heated respiratory humidifier
800CC SUCTION CANISTER WITH HYDROPHOBIC FILTER WITH RED LID
BEMIS MANUFACTURING COMPANY
424410 10
Not in Commercial Distribution

  • 20073088149842 ()
  • 00073088149848 ()

  • Total Volume: 800 Milliliter
424410 10

  • Surgical suction system collection container, single-use
GEAR H-BASE WITH 3 POLE PUMP AD WITH QWIK-IT
PRYOR PRODUCTS
1100G-QK
In Commercial Distribution

  • 00761887004412 ()
1100G-QK

  • Freestanding/bed-attached intravenous pole
Stellaris Elite PC with Laser with Version 5+ Software
Bausch & Lomb Incorporated
BL15455
In Commercial Distribution

  • 00757770524532 ()
BL15455

  • Phacoemulsification/vitrectomy system
1.75Dia With Three .250 SlotsLight Handle Cover With Flange
DEROYAL INDUSTRIES, INC.
BE3-F
In Commercial Distribution

  • 50749756955268 ()
  • 00749756955263 ()


  • Instrument/equipment drape, single-use, sterile
Ureteral Dilator With AQ, Hydrophilic Coating With Modified Taper
COOK INCORPORATED
G17636
In Commercial Distribution

  • 00827002176362 ()
AQ-076012-TP

  • Endoscopic-access dilator, single-use
with Attached Air Plugs for Use with Nebulizer Kit
Omron Healthcare, Inc.
C915
In Commercial Distribution

  • 00073796391508 ()
  • 10073796391505 ()
C915

  • Nebulizing system delivery set, single-use
No Description
BIOMET SPINE LLC
LV00350
In Commercial Distribution

  • 00888480479765 ()

  • PLUG STARTER W/FIXED HANDLE WITH TEAR-DROP SILICONE HANDLE FOR USE WITH LINEUM SYSTEM
LV00350

  • Surgical screwdriver, reusable
Syringes with needle
Flex Source International, Inc.
Part Number: 2523
In Commercial Distribution

  • 00860006105068 ()
  • 00860006105044 ()


  • Medication transfer set
Syringes with needle
Flex Source International, Inc.
Part Number: 2523
In Commercial Distribution

  • 00860006105020 ()
  • 00860006105006 ()


  • Medication transfer set
Preassembeled with Stylet
SYNCRO MEDICAL INNOVATIONS
12 Fr
In Commercial Distribution

  • 10860000931325 ()
  • 00860000931328 ()

  • Catheter Gauge: 12 French
  • 12 FR (4.2mm) X 52" (130cm)
GFTB 412

  • Nasogastric feeding tube
Preassembeled with Stylet
SYNCRO MEDICAL INNOVATIONS
10 Fr
In Commercial Distribution

  • 10860000931318 ()
  • 00860000931311 ()

  • Catheter Gauge: 10 French
  • 10 FR (3.7mm) X 40" (100cm)
GFTB 410

  • Nasogastric feeding tube
Preassembeled with Stylet
SYNCRO MEDICAL INNOVATIONS
8 Fr
In Commercial Distribution

  • 10860000931301 ()
  • 00860000931304 ()

  • Catheter Gauge: 8 French
  • 8 FR (3.3mm) X 32" (80cm)
GFTB 408

  • Nasogastric feeding tube
PFI117 with CVIPC
HU-FRIEDY MFG. CO., LLC
CI5509
Not in Commercial Distribution

  • 10889950042967 ()
CI5509

  • Dental restoration carver, resin
SCREWDRIVER WITH SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X0500054
In Commercial Distribution

  • 00681490489393 ()


  • Orthopaedic implantation sleeve, reusable
MAR-AAC1 with MCBLS
HU-FRIEDY MFG. CO., LLC
RCP5508
In Commercial Distribution

  • 10889950087722 ()
RCP5508

  • Endodontic plugger
CSA6 with CSJH6
HU-FRIEDY MFG. CO., LLC
SP5507
Not in Commercial Distribution

  • 10889950097714 ()
SP5507

  • Dental spatula, reusable
ARTHROSCOPY WITH POUCH-LF
MEDLINE INDUSTRIES, INC.
DYNJ902614I
In Commercial Distribution

  • 10195327214234 ()
DYNJ902614I

  • General surgical procedure kit, non-medicated, single-use
MEDIPORT WITH BIOPATCH
MEDLINE INDUSTRIES, INC.
DYNDC2219A
In Commercial Distribution

  • 40193489348577 ()
  • 10193489348576 ()
DYNDC2219A

  • General surgical procedure kit, non-medicated, single-use
CENTESIS WITH TURKEL
Cardinal Health 200, LLC
30-0307K
In Commercial Distribution

  • 50888439873021 ()
  • 10888439873023 ()
30-0307K

  • General surgical procedure kit, medicated
CENTESIS WITH TURKEL
Cardinal Health 200, LLC
30-0307J
In Commercial Distribution

  • 50888439872369 ()
  • 10888439872361 ()
30-0307J

  • General surgical procedure kit, medicated
with Introducer, 4.5F
Laborie Medical Technologies Canada ULC
9021P4480
In Commercial Distribution

  • 10627825007099 ()
  • 00627825007085 ()


  • Urodynamic manometric catheter, non-electronic
with Introducer, 4.5F
Laborie Medical Technologies Canada ULC
9021P4471
In Commercial Distribution

  • 10627825007068 ()
  • 00627825007054 ()


  • Urodynamic manometric catheter, non-electronic
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