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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Medicom Confidence - Earloop Face Masks - ASTM Level 3 Protection - Blue
AMD Medicom Inc
214115-CAN
Not in Commercial Distribution

  • 00686864059264 ()
  • 00686864059257 ()
  • 00686864059271 ()
214115-CAN

  • Surgical/medical face mask, non-antimicrobial, single-use
Medicom Confidence - Earloop Face Masks - ASTM Level 3 Protection - Blue
AMD Medicom Inc
214115
In Commercial Distribution

  • 00686864059110 ()
  • 00686864059103 ()
  • 00686864059097 ()
214115

  • Surgical/medical face mask, non-antimicrobial, single-use
MEDICOM CONFIDENCE - EARLOOP FACE MASK - LEVEL 1 - BLUE
AMD Medicom Inc
212915-US
Not in Commercial Distribution

  • 00686864059042 ()
  • 00686864059035 ()
  • 00686864059059 ()
212915-US

  • Surgical/medical face mask, non-antimicrobial, single-use
EARLOOP FACE MASK - LEVEL 1 - BLUE
AMD Medicom Inc
212915
In Commercial Distribution

  • 00686864058854 ()
  • 00686864058847 ()
  • 00686864058991 ()
212915

  • Surgical/medical face mask, non-antimicrobial, single-use
Medicom Connections - Earloop Face Masks - Level 3 - Black
AMD Medicom Inc
208092
In Commercial Distribution

  • 00686864059127 ()
  • 00686864058144 ()
  • 00686864058151 ()
208092

  • Surgical/medical face mask, non-antimicrobial, single-use
Medicom Connections - Earloop Face Masks - Level 3 - Blue
AMD Medicom Inc
208015
Not in Commercial Distribution

  • 00686864058137 ()
  • 00686864058120 ()
  • 00686864060109 ()
208015

  • Surgical/medical face mask, non-antimicrobial, single-use
Box of 24 masks; Note: individual masks are NOT for sale. Intended use: The ClearMask Transparent Surgical Face Mask is intended for use in healthcare settings, such as in operating rooms, or in other medical procedures such as dental, isolation and veterinary procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device allows for full view of the face and facial expressions, particularly the nose and mouth areas. The device is indicated for over-the-counter use. The device is disposable and is indicated for single use. The device is not provided sterile.
Clearmask, LLC
v1.0
In Commercial Distribution

  • 10860005106025 ()
  • 00860005106028 ()
  • 20860005106022 ()
  • 00860005106035 ()


  • Surgical/medical face mask, single-use
Premium-PPE Amerishield AirMax Procedure Mask, ASTM Level 3, 4-Ply Adult Blue, Inner Carton of 50 Masks, K211275
Premiumestore, LLC
PPE-M-AS-SUR-S
In Commercial Distribution

  • 00860004941927 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Premium-PPE Amerishield Surgical Mask, ASTM Level 2, 3-Ply Adult Blue, Inner Carton of 50 Masks, K211520
Premiumestore, LLC
PPE-M-AS-SUR-LVL2-S
In Commercial Distribution

  • 00860004941910 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
The nPro single use, disposable surgical masks provide excellent protection and are designed to meet the ASTM F2100-19 Level 1 requirements. The 3-ply pleated mask fabric can be vertically adjusted to cover the mouth and nose. The masks have an enclosed flexible nose wire and feature soft and strong ear-loops to ensure a snug and comfortable fit. All materials are not made with natural rubber latex.
N P Medical Inc.
6412107
In Commercial Distribution

  • 00860004362913 ()

  • Length: 17.5 Centimeter
  • Width: 9.5 Centimeter
6412107

  • Surgical/medical face mask, single-use
The nPro single use, disposable surgical masks provide excellent protection and are designed to meet the ASTM F2100-19 Level 1 requirements. The 3-ply pleated mask fabric can be vertically adjusted to cover the mouth and nose. The masks have an enclosed flexible nose wire and feature soft and strong ear-loops to ensure a snug and comfortable fit. All materials are not made with natural rubber latex.
N P Medical Inc.
6409996
In Commercial Distribution

  • 00860004362906 ()

  • Length: 17.5 Centimeter
  • Width: 9.5 Centimeter
6409996

  • Surgical/medical face mask, single-use
ASTM Level 3 Surgical Mask - Box of 50 -
Taiji Medical Supplies Inc.
A1
In Commercial Distribution

  • 10860007355902 ()
  • 00860007355905 ()
  • 00860007355950 ()

  • Length: 175 Millimeter
  • Width: 95 Millimeter
16752

  • Surgical/medical face mask, single-use
The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single-use, disposable device, provided non-sterile.
Defender Safety Inc.
DSM-SM03-B
In Commercial Distribution

  • 00860007209536 ()
DSM-SM03-B

  • Surgical/medical face mask, single-use
The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single-use, disposable device, provided non-sterile.
Defender Safety Inc.
DSM-PM03-B
In Commercial Distribution

  • 00860007209529 ()
DSM-PM03-B

  • Surgical/medical face mask, single-use
The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single-use, disposable device, provided non-sterile.
Defender Safety Inc.
UDSM-PM02-B
In Commercial Distribution

  • 00860007209512 ()
UDSM-PM02-B

  • Surgical/medical face mask, single-use
The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single-use, disposable device, provided non-sterile.
Defender Safety Inc.
DSM-PM01-B
In Commercial Distribution

  • 00860007209505 ()
DSM-PM01-B

  • Surgical/medical face mask, single-use
No Description
M.Y.T. USA Corp.
ASTM LEVEL 3 MASK
In Commercial Distribution

  • 00860009046450 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Ear Loop Mask
APOTHECARY PRODUCTS, LLC
69002WM
In Commercial Distribution

  • 20681131161750 ()
  • 00681131161756 ()
  • 40681131161754 ()
  • 10681131161753 ()


  • Surgical/medical face mask, antimicrobial, single-use
CTX BLACK FACE MASK, SF, L3
HU-FRIEDY MFG. CO., LLC
GCFBKSF-HF
In Commercial Distribution

  • 10889950140243 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
Mask Sample Pack - Assorted Standard
HU-FRIEDY MFG. CO., LLC
SP-AFM
In Commercial Distribution

  • 10889950134082 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
Mask Sample Pack - Secure Fit
HU-FRIEDY MFG. CO., LLC
SP-SFFM
In Commercial Distribution

  • 10889950133542 ()
Crosstex™ SecureFit™

  • Surgical/medical respirator, non-antimicrobial, single-use
Mask Sample Pack-SF Black, Blue & White
HU-FRIEDY MFG. CO., LLC
SP-SFBBW
In Commercial Distribution

  • 10889950140038 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
Medical Bed - CITADEL PLUS - USA - No Outlet
Arjohuntleigh AB
FXX11A1C1ABWBB
In Commercial Distribution

  • 05056097365121 ()


  • Bariatric bed
Medical Bed - CITADEL PLUS - USA
Arjohuntleigh AB
FXX11A1B3AMABA
In Commercial Distribution

  • 05056097327822 ()


  • Bariatric bed
Medical Bed - CITADEL PLUS - USA - No Outlet
Arjohuntleigh AB
FXX11A1C1ACABB
In Commercial Distribution

  • 05056097301853 ()


  • Bariatric bed
Medical Bed - CITADEL PLUS - USA - No Outlet
Arjohuntleigh AB
FXX11A1C1ACABA
In Commercial Distribution

  • 05056097301846 ()


  • Bariatric bed
Medical Bed - CITADEL PLUS - USA
Arjohuntleigh AB
FXX11C3C4AMABA
In Commercial Distribution

  • 05056097368429 ()


  • Bariatric bed
Medical Bed - CITADEL PLUS - USA
Arjohuntleigh AB
FXX11C3B4AMABB
In Commercial Distribution

  • 05056097342306 ()


  • Bariatric bed
Medical Bed - CITADEL PLUS - USA
Arjohuntleigh AB
FXX11C2B3AMABA
In Commercial Distribution

  • 05056097342290 ()


  • Bariatric bed
Medical Bed - CITADEL PLUS - USA
Arjohuntleigh AB
FXX11C1B1AMABA
In Commercial Distribution

  • 05056097342283 ()


  • Bariatric bed
Earloop Procedure Mask, blue, contains forming nosepiece, free of metal components, MRI compatible, ASTM F2100 Level 2
Strong Medical Partners LLC
5303
In Commercial Distribution

  • 10850005354366 ()
  • 00850005354369 ()
5303

  • Surgical/medical face mask, single-use
Earloop surgical mask, blue, contains forming nosepiece (metal wire), ASTM F2100 Level 3
Strong Medical Partners LLC
5311
In Commercial Distribution

  • 10850005354359 ()
  • 00850005354352 ()
5311

  • Surgical/medical face mask, non-antimicrobial, single-use
Fluid Resistant Masks with Face Shields
ROBERT BUSSE & CO., INC.
373
In Commercial Distribution

  • 00849233000957 ()
  • 10849233000954 ()
  • 20849233000951 ()
373

  • Surgical/medical face mask, single-use
Procedural Masks
ROBERT BUSSE & CO., INC.
371
In Commercial Distribution

  • 20849233000937 ()
  • 10849233000930 ()
  • 00849233000933 ()
371

  • Surgical/medical face mask, single-use
Isolation Masks
ROBERT BUSSE & CO., INC.
370
In Commercial Distribution

  • 00849233000926 ()
  • 10849233000923 ()
  • 20849233000920 ()
370

  • Surgical/medical face mask, single-use
Procedural Facemasks Box of 50
TIDI PRODUCTS, LLC
9030
Not in Commercial Distribution

  • 10618125128430 ()
  • 00618125128433 ()
  • 01618125128432 ()
9031

  • Medical equipment/instrument drape, single-use
No Description
Dynarex Corporation
2208
In Commercial Distribution

  • 00616784220833 ()
  • 00616784220826 ()
  • 00616784220819 ()


  • Surgical/medical face mask, reprocessed
No Description
Dynarex Corporation
2206
In Commercial Distribution

  • 00616784220628 ()
  • 00616784220611 ()


  • Surgical/medical face mask, single-use
No Description
Dynarex Corporation
2205
In Commercial Distribution

  • 00616784220536 ()
  • 00616784220529 ()
  • 00616784220512 ()


  • Surgical/medical face mask, single-use
No Description
Dynarex Corporation
2204
In Commercial Distribution

  • 00616784220437 ()
  • 00616784220420 ()
  • 00616784220413 ()


  • Surgical/medical face mask, single-use
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