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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The CINTAS CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Large barrier surface area, 7" X 7" (17.5 cm X 17.5 cm), maximizes isolation between rescuer and patient. The barrier material is attached to a short bite block containing TWO (2) silicone valves which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilations much easier when doing the head tilt/chin lift procedure. The short bite block, 2 cm in length reduces the risk of pushing the patient's tongue back and does not require a prescription Two grips extend away from the bite block to provide a means to help the rescuer hold the small bite bloc and also help release the barrier from the patient's face between resuscitation breaths. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. ISO-SHIELD (TM) of Rondex MADE IN USA
RONDEX PRODUCTS, INCORPORATED
CINTAS #9550-G w Black Key Ring/Belt Loop Case & Gloves
In Commercial Distribution

171110

  • Cardiopulmonary resuscitation mask, single-use
The RONDEX CPR REDI-SHIELD model #9850-G comes in a case with a key ring and gloves. It is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. REDI-SHIELD(TM) of Rondex MADE IN USA.
RONDEX PRODUCTS, INCORPORATED
9850-G (packaged in key ring case)
In Commercial Distribution

9850-G

  • Cardiopulmonary resuscitation mask, single-use
The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. The REDI-SHIELD with a bite block advantage is very compact and is ideal for unitized packaging in first aid kits and key ring cases. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. REDI-SHIELD(TM) of Rondex MADE IN USA.
RONDEX PRODUCTS, INCORPORATED
9850 (Packaged in key ring case)
In Commercial Distribution

9850

  • Cardiopulmonary resuscitation mask, single-use
The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. The REDI-SHIELD with a bite block advantage is very compact and is ideal for unitized packaging in first aid kits and key ring cases. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. REDI-SHIELD(TM) of Rondex MADE IN USA.
RONDEX PRODUCTS, INCORPORATED
9800-G (package in poly bag with gloves)
In Commercial Distribution

9800-G

  • Cardiopulmonary resuscitation mask, single-use
The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. The REDI-SHIELD with a bite block advantage is very compact and is ideal for unitized packaging in first aid kits and key ring cases. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. REDI-SHIELD(TM) of Rondex MADE IN USA
RONDEX PRODUCTS, INCORPORATED
9800 (packaged in poly bag)
In Commercial Distribution

9800

  • Cardiopulmonary resuscitation mask, single-use
The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Large barrier surface area, 7" X 7" (17.5 cm X 17.5 cm), maximizes isolation between rescuer and patient. The barrier material is attached to a short bite block containing TWO (2) silicone valves which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilations much easier when doing the head tilt/chin lift procedure. The short bite block, 2 cm in length reduces the risk of pushing the patient's tongue back and does not require a prescription Two grips extend away from the bite block to provide a means to help the rescuer hold the small bite bloc and also help release the barrier from the patient's face between resuscitation breaths. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. ISO-SHIELD (TM) of Rondex MADE IN USA
RONDEX PRODUCTS, INCORPORATED
9550-G (w Key Ring/Belt Loop Case & Gloves)
In Commercial Distribution

9550-G

  • Cardiopulmonary resuscitation mask, single-use
The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Large barrier surface area, 7" X 7" (17.5 cm X 17.5 cm), maximizes isolation between rescuer and patient. The barrier material is attached to a short bite block containing TWO (2) silicone valves which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilations much easier when doing the head tilt/chin lift procedure. The short bite block, 2 cm in length reduces the risk of pushing the patient's tongue back and does not require a prescription Two grips extend away from the bite block to provide a means to help the rescuer hold the small bite bloc and also help release the barrier from the patient's face between resuscitation breaths. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. ISO-SHIELD (TM) of Rondex MADE IN USA
RONDEX PRODUCTS, INCORPORATED
9500 (packaged in poly bag)
In Commercial Distribution

9500

  • Cardiopulmonary resuscitation mask, single-use
A convenience kit consisting of 15 Advanced Digital Ovulation tests + 1 Rapid Detection pregnancy tests
SPD SWISS PRECISION DIAGNOSTICS GMBH
Advanced Digital Ovulation Test Kit
In Commercial Distribution

  • 00633472602412 ()
  • 10633472602419 ()
N/A

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
  • Natural conception assistance kit
A convenience kit consisting of 30 Advanced Digital Ovulation tests + 2 Rapid Detection pregnancy tests
SPD SWISS PRECISION DIAGNOSTICS GMBH
Advanced Digital Ovulation Test Kit
In Commercial Distribution

  • 00633472602405 ()
  • 10633472602402 ()
N/A

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
  • Natural conception assistance kit
Clearblue Ovul Dig 30ct. US
SPD SWISS PRECISION DIAGNOSTICS GMBH
Digital Ovulation Test
In Commercial Distribution

  • 00633472602399 ()
  • 10633472602396 ()
  • 00633472000096 ()


  • Natural conception assistance kit
CB Birth Control Refill 15ct US
SPD SWISS PRECISION DIAGNOSTICS GMBH
Digital Ovulation Test
In Commercial Distribution

  • 10633472602389 ()
  • 00633472602382 ()
  • 00633472000096 ()
N/A

  • Natural conception assistance kit
A convenience kit consisting of 15 Digital Ovulation Tests, Digital Basal Thermometer and 3 month subscription to Natural Cycles app
SPD SWISS PRECISION DIAGNOSTICS GMBH
Birth Control Kit
In Commercial Distribution

  • 10633472602372 ()
  • 00633472602375 ()
N/A

  • Natural conception assistance kit
Pocket Pal II Kit,White, Disp pkg
AMERICAN DIAGNOSTIC CORP
116WQ
In Commercial Distribution

  • 00634782564834 ()
  • 00634782065164 ()
116WQ

  • Bandage scissors, reusable
Two transfer bags (150 mL and 200 mL) and one 25 mL freezing bag for blood component processing and freezing.
Global Life Sciences Solutions USA LLC
791-02
In Commercial Distribution

  • 30636207302442 ()
  • 00636207302441 ()

  • Total Volume: 25 Milliliter
  • recommended fill volume
791-02

  • Umbilical cord blood collection set
All-purpose, First Aid Kit, 140 items, Including One Carrying Case: 34- Sheer Antibacterial* Bandages 5/8 in. x 2 1/4 in. (1.5 cm x 5.7 cm), 30- Sheer Antibacterial* Bandages 3/4 in. x 3 in. (1.9 cm x 7.6 cm), 15- Fabric Antibacterial* Bandages 5/8 in. x 2 1/4 in. (1.5 cm x 5.7 cm), 14- Sheer Antibacterial* Bandages 7/8 in. (2.2 cm), 12- Butterfly Closures 1 3/4 in. x 3/8 in. (4.4 cm x .95 cm), 10- Fabric Antibacterial* Bandages 3/4 in. x 3 in. (1.9 cm x 7.6 cm), 5- Fabric Antibacterial* Bandages 1 in. x 3 in. (2.5 cm x 7.6 cm), 2- Sheer Antibacterial* Bandages 2 1/4 in. x 3 in. (5.7 cm x 7.6 cm), 1- Instant Cold Pack 5 in. x 6 in. (12.7 cm x 15.3 cm), 1- Paper Tape Roll 1/2 in. x 5 yd. (1.2 cm x 4.5 m), 4- Hand Cleansing Wipes 4 3/4 in. x 7 3/4 in. (12 cm x 19.6 cm), 2- Triple Antibiotic Ointment 1/32 oz. (0.9 g), 6- Gauze Pads, 2 in. x 2 in. (5 cm x 5 cm) 2- Non-Stick** Pads, 2 in. x 3 in. (5 cm x 7.6 cm), 1- Carrying Case, 1- First Aid Guide
CHAIN DRUG MARKETING ASSOCIATION, INC.
635515998537
In Commercial Distribution

  • 10635515998534 ()
  • 00635515998537 ()
  • 20635515998531 ()


  • First aid kit, medicated
FPPL Quality Choice DPS +/-
CHAIN DRUG MARKETING ASSOCIATION, INC.
FPPL
In Commercial Distribution

  • 00635515900493 ()
  • 10635515900490 ()
  • 00633472000133 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
FPPL Quality Choice SPS +/-
CHAIN DRUG MARKETING ASSOCIATION, INC.
FPPL
In Commercial Distribution

  • 10635515900483 ()
  • 00635515900486 ()
  • 10635515800127 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
DRILL - A.O QUICK RELEASE 3.2mm DIA x 195mm
DE SOUTTER MEDICAL LIMITED
D55-110
In Commercial Distribution

  • 15051471081878 ()
  • 05051471081871 ()
D55-110

  • Fluted surgical drill bit, single-use
DRILL - A.O QUICK RELEASE 3.2mm DIA x 145mm
DE SOUTTER MEDICAL LIMITED
D55-109
In Commercial Distribution

  • 15051471081861 ()
  • 05051471081864 ()
D55-109

  • Fluted surgical drill bit, single-use
DRILL - A.O QUICK RELEASE 2.7mm DIA x 125mm
DE SOUTTER MEDICAL LIMITED
D55-108
In Commercial Distribution

  • 15051471081854 ()
  • 05051471081857 ()
D55-108

  • Fluted surgical drill bit, single-use
DRILL - A.O QUICK RELEASE 2.7mm DIA x 100mm
DE SOUTTER MEDICAL LIMITED
D55-107
In Commercial Distribution

  • 15051471081847 ()
  • 05051471081840 ()
D55-107

  • Fluted surgical drill bit, single-use
DRILL - A.O QUICK RELEASE 2.5mm DIA x 180mm
DE SOUTTER MEDICAL LIMITED
D55-106
In Commercial Distribution

  • 15051471081830 ()
  • 05051471081833 ()
D55-106

  • Fluted surgical drill bit, single-use
DRILL - A.O QUICK RELEASE 2.5mm DIA x 110mm
DE SOUTTER MEDICAL LIMITED
D55-105
In Commercial Distribution

  • 15051471081823 ()
  • 05051471081826 ()
D55-105

  • Fluted surgical drill bit, single-use
DRILL - A.O QUICK RELEASE 2.0mm DIA x 125mm
DE SOUTTER MEDICAL LIMITED
D55-104
In Commercial Distribution

  • 15051471081816 ()
  • 05051471081819 ()
D55-104

  • Fluted surgical drill bit, single-use
DRILL - A.O QUICK RELEASE 2.0mm DIA x 100mm
DE SOUTTER MEDICAL LIMITED
D55-103
In Commercial Distribution

  • 15051471081809 ()
  • 05051471081802 ()
D55-103

  • Fluted surgical drill bit, single-use
DRILL - A.O QUICK RELEASE 1.5mm DIA x 110mm
DE SOUTTER MEDICAL LIMITED
D55-102
In Commercial Distribution

  • 15051471081793 ()
  • 05051471081796 ()
D55-102

  • Fluted surgical drill bit, single-use
DRILL - A.O QUICK RELEASE 1.5mm DIA x 85mm
DE SOUTTER MEDICAL LIMITED
D55-101
In Commercial Distribution

  • 15051471081786 ()
  • 05051471081789 ()
D55-101

  • Fluted surgical drill bit, single-use
DRILL - A.O QUICK RELEASE 1.1mm DIA x 60mm
DE SOUTTER MEDICAL LIMITED
D55-100
In Commercial Distribution

  • 15051471081779 ()
  • 05051471081772 ()
D55-100

  • Fluted surgical drill bit, single-use
DRILL - PLAIN SHANK 5.0mm DIA x 180mm
DE SOUTTER MEDICAL LIMITED
D50-112
In Commercial Distribution

  • 15051471081335 ()
  • 05051471081338 ()
D50-112

  • Fluted surgical drill bit, single-use
DRILL - PLAIN SHANK 4.8mm DIA x 127mm
DE SOUTTER MEDICAL LIMITED
D50-111
In Commercial Distribution

  • 15051471081328 ()
  • 05051471081321 ()
D50-111

  • Fluted surgical drill bit, single-use
DRILL - PLAIN SHANK 4.5mm DIA x 180mm
DE SOUTTER MEDICAL LIMITED
D50-110
In Commercial Distribution

  • 15051471081311 ()
  • 05051471081314 ()
D50-110

  • Fluted surgical drill bit, single-use
DRILL - PLAIN SHANK 4.5mm DIA x 156mm
DE SOUTTER MEDICAL LIMITED
D50-109
In Commercial Distribution

  • 15051471081304 ()
  • 05051471081307 ()
D50-109

  • Fluted surgical drill bit, single-use
DRILL - PLAIN SHANK 4.0mm DIA x 156mm
DE SOUTTER MEDICAL LIMITED
D50-108
In Commercial Distribution

  • 15051471081298 ()
  • 05051471081291 ()
D50-108

  • Fluted surgical drill bit, single-use
DRILL - PLAIN SHANK 3.5mm DIA x 180mm
DE SOUTTER MEDICAL LIMITED
D50-107
In Commercial Distribution

  • 15051471081281 ()
  • 05051471081284 ()
D50-107

  • Fluted surgical drill bit, single-use
DRILL - PLAIN SHANK 3.5mm DIA x 95mm
DE SOUTTER MEDICAL LIMITED
D50-106
In Commercial Distribution

  • 15051471081274 ()
  • 05051471081277 ()
D50-106

  • Fluted surgical drill bit, single-use
DRILL - PLAIN SHANK 3.2mm DIA x 180mm
DE SOUTTER MEDICAL LIMITED
D50-105
In Commercial Distribution

  • 15051471081267 ()
  • 05051471081260 ()
D50-105

  • Fluted surgical drill bit, single-use
DRILL - PLAIN SHANK 3.2mm DIA x 130mm
DE SOUTTER MEDICAL LIMITED
D50-104
In Commercial Distribution

  • 15051471081250 ()
  • 05051471081253 ()
D50-104

  • Fluted surgical drill bit, single-use
DRILL - PLAIN SHANK 2.7mm DIA x 85mm
DE SOUTTER MEDICAL LIMITED
D50-103
In Commercial Distribution

  • 15051471081243 ()
  • 05051471081246 ()
D50-103

  • Fluted surgical drill bit, single-use
DRILL - PLAIN SHANK 2.5mm DIA x 95mm
DE SOUTTER MEDICAL LIMITED
D50-102
In Commercial Distribution

  • 15051471081236 ()
  • 05051471081239 ()
D50-102

  • Fluted surgical drill bit, single-use
DRILL - PLAIN SHANK 2.0mm DIA x 85mm
DE SOUTTER MEDICAL LIMITED
D50-101
In Commercial Distribution

  • 15051471081229 ()
  • 05051471081222 ()
D50-101

  • Fluted surgical drill bit, single-use
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