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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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19" x 7" (45.7 cm x 17.8 cm) hot & cold therapy neck wrap with elastic strap to relieve pain, stiffness, and tension.
MEIJER, INC.
3458396
In Commercial Distribution

  • 00708820523432 ()

  • Area/Surface Area: 133 Square inch


  • Hot/cold therapy pack, reusable
Infant Heel Warmer Fold To Activate Adhesive Heel Strap Non-sterile Non-toxic Food Grade Sodium Acetate And Water 3.5 X 5.5 Inch MediChoice
OWENS & MINOR DISTRIBUTION, INC.
IHW002
In Commercial Distribution

  • 30885632057759 ()
  • 20885632057752 ()
  • 10885632057755 ()


  • Hot/cold therapy pack, single-use
No Description
NORAV MEDICAL LTD.
SOFT-NH300-2
In Commercial Distribution

  • 07290110252700 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Far Infra Red photo therapy unit indicated for pain relief and to increase local circulation. It utilizes thermal far infra-red therapeutic heating, therapeutic manual massage, and is approved for relief of muscle and joint pain and stiffness, muscle relaxation, temporary increase in circulation and for temporary arthritis pain relief.
MIGUN LIFE INC
HY777
In Commercial Distribution

  • B344HY7770 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Manual
CNSystems Medizintechnik AG
V3.5.3
Not in Commercial Distribution

  • 09120073931344 ()
21-FHZU-10002

  • Noninvasive haemodynamic monitoring system
Unit; 2.3
CNSystems Medizintechnik AG
V2.3
Not in Commercial Distribution

  • 09120073930590 ()
00130

  • Noninvasive haemodynamic monitoring system
Unit;
CNSystems Medizintechnik AG
V3.5.1
Not in Commercial Distribution

  • 09120073930293 ()
21-FHZU-10002

  • Noninvasive haemodynamic monitoring system
No Description
BELMONT INSTRUMENT CORPORATION
902-00001A
Not in Commercial Distribution

  • 10896128002135 ()


  • Extravascular-circulation hyperthermia system
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
W009
Not in Commercial Distribution

  • 00816879021745 ()
74432

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
No Description
Respironics Novametrix, LLC
7900
In Commercial Distribution

  • 00884838083363 ()
DU1051674

  • Monitoring spirometer, electrical
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