bayer.comKovaltry
Antihemophilic Factor (Recombinant)
Bayer HealthCare, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2243252 | 2243252 | Bayer HealthCare, LLC | 1 | N | 2026-01-01 | 36 Columbia Rd Morristown NJ US 07960 |
| 2248903 | 3000206585 | BAYER HEALTHCARE LLC, CONSUMER CARE | 1 | Y | 2026-01-01 | 36 Columbia Rd MORRISTOWN NJ US 07960 |
| 1910953 | 1910953 | BAYER HEALTHCARE LLC | 1 | N | 2020-04-25 | 12707 SHAWNEE MISSION PKWY Shawnee Mission KS US 66216 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00616258003832 | AVX - AVX CUS CATHETER, FG PKG | 763-780-4555 | michael.burnside@bayer.com |
| 00616258003849 | XVG - XVG CUS CATHETER, FG PKG | 763-780-4555 | michael.burnside@bayer.com |
| 00616258003856 | SPIROFLEX VG - SPIROFLEX VG CUS CATH FG PKG | 763-780-4555 | michael.burnside@bayer.com |
| 00616258003887 | SPIROFLEX - SPIROFLEX CUS CATH, FG PKG | 763-780-4555 | michael.burnside@bayer.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 188736 | 1802181199 | P020014 | ESSURE SYSTEM | HHS | 2002-11-04 |
| 59665 | 1304371515 | K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) | NUH | 2015-12-22 |
| 59665 | 1460791089 | K052259 | DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406 | GEH | 2005-12-14 |
| 188736 | 1463413124 | K042784 | MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM | DXT | 2004-12-10 |
| 59665 | 1671315556 | K031697 | DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226 | GEH | 2003-08-29 |
| 59665 | 1129076330 | ||||
| 59665 | 1509386015 | ||||
| 200860 | 1509386015 | ||||
| 59665 | 1657124756 | ||||
| 59665 | 1749212935 | ||||
| 59665 | 1917433349 | ||||
| 59665 | 1932198061 | ||||
| 188736 | 2019301403 |
Product Codes Associated With Registrations#
NDC#
Kovaltry
Antihemophilic Factor (Recombinant)
Kovaltry
Antihemophilic Factor (Recombinant)
Kovaltry
Antihemophilic Factor (Recombinant)
Kovaltry
Antihemophilic Factor (Recombinant)
Jivi
Antihemophilic Factor (Recombinant) Pegylated-aucl
Jivi
Antihemophilic Factor (Recombinant) Pegylated-aucl
Jivi
Antihemophilic Factor (Recombinant) Pegylated-aucl
Jivi
Antihemophilic Factor (Recombinant) Pegylated-aucl
Jivi
Antihemophilic Factor (Recombinant) Pegylated-aucl
Alka-Seltzer Cool Action Heartburn Relief
Calcium Carbonate
Alka-Seltzer Heartburn Relief
calcium carbonate
Alka-Seltzer Plus Severe Cold PowerFast Fizz
aspirin, chlorpheniramine maleate, phenylephrine bitartrate
Alka-Seltzer Plus Severe Cold Powerfast Fizz Night
aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate
Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz
aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate
Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy
asprin, dextromethorphan hydrobromide, phenylephrine bitartrate
Alka-Seltzer Plus Severe Cold PowerFast Fizz
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate
PHILLIPS ORIGINAL MILK OF MAGNESIA
PHILLIPS ORIGINAL MILK OF MAGNESIA
PHILLIPS FRESH MINT MILK OF MAGNESIA
PHILLIPS FRESH MINT MILK OF MAGNESIA
Phillips Milk Of Magnesia Wild Cherry
Phillips Milk Of Magnesia Wild Cherry
Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night Powermax
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride
Aleve Arthritis Pain Gel
Diclofenac Sodium
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu
dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride, doxylamine succinate
Aleve Headache Pain
Naproxen Sodium
Alka-Seltzer Extra Strength Heartburn ReliefChews
Calcium carbonate
Alka-Seltzer Heartburn
Anhydrous citric acid, Sodium bicarbonate (heat-treated)
AleveX
camphor and menthol
AleveX
camphor and menthol
Alka-Seltzer Kids Tummy ReliefChews
calcium carbonate and dimethicone
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz
chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride
Alka-Seltzer Cool Action Extra Strength ReliefChews Mint
Calcium Carbonate
Alka-Seltzer Ultra Strength Heartburn ReliefChews
Calcium Carbonate
Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz
aspirin, chlorpheniramine maleate, phenylephrine bitartrate
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and Night
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride
AleveX
camphor and menthol
Bayer Headache
Aspirin and caffeine
Astepro Allergy
Azelastine HCl
Children Astepro Allergy
Azelastine HCl
Alka-Seltzer Plus Severe Cold Night PowerFast Fizz
aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate
PMA#
ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS
BAYER HEALTHCARE, DIAGNOSTICS DIVISION
ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS
BAYER HEALTHCARE, LLC
CIBA CORNING ACS PSA IMMUNOASSAY
BAYER HEALTHCARE, LLC
CIBA CORNING ACS PSA IMMUNOASSAY
BAYER HEALTHCARE, LLC
CIBA CORNING ACS PSA IMMUNOASSAY
BAYER HEALTHCARE, LLC
BIOSTATOR GCIIS
BAYER HEALTHCARE
BIOSTATOR GCIIS
BAYER HEALTHCARE
BIOSTATOR GCIIS
BAYER HEALTHCARE
PMN#
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
Bayer HealthCare LLC
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
BAYER HEALTHCARE, LLC
Contour Next USB Blood Glucose Monitoring System
BAYER HEALTHCARE
Contour Next Control Solution
BAYER HEALTHCARE
CONTOUR NEXT EZ BLOOD GLUCOSE METER
BAYER HEALTHCARE LLC
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
BAYER HEALTHCARE
CONTOUR NEXT BLOOD GLUCOSE METER
BAYER HEALTHCARE LLC
CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
BAYER HEALTHCARE
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
BAYER HEALTHCARE
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
BAYER HEALTHCARE, LLC
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
BAYER HEALTHCARE
DIDGET WORLD REPORTS
BAYER HEALTHCARE LLC
DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080
BAYER HEALTHCARE, LLC
CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM
BAYER HEALTHCARE
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
BAYER HEALTHCARE, LLC
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
BAYER HEALTHCARE, LLC
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
BAYER HEALTHCARE, LLC
CLINITEK ADVANTUS, MODEL 1420
BAYER HEALTHCARE, LLC
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
BAYER HEALTHCARE, LLC
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080
BAYER HEALTHCARE
ADVIA IMS CPSA CONTROL
BAYER HEALTHCARE, LLC
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080
BAYER HEALTHCARE
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
BAYER HEALTHCARE, LLC
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
BAYER HEALTHCARE, LLC
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
BAYER HEALTHCARE, LLC
ADVIA IMS GLUCOSE ASSAY
BAYER HEALTHCARE, LLC
ADVIA CHEMISTRY MICROALBUMIN CONTROLS
BAYER HEALTHCARE LLC
ADVIA IMS LITHIUM ASSAY
BAYER HEALTHCARE, LLC
ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
BAYER HEALTHCARE, LLC
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
BAYER HEALTHCARE, LLC
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
BAYER HEALTHCARE, LLC
ASCENSIA ELITE DIABETES CARE SYSTEM
BAYER HEALTHCARE, LLC
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
BAYER HEALTHCARE, DIAGNOSTICS DIVISION
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
BAYER HEALTHCARE, LLC
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
BAYER HEALTHCARE, LLC
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
BAYER HEALTHCARE, LLC
CO2 CALIBRATOR/DILUENT
BAYER HEALTHCARE, DIAGNOSTICS DIVISION
CLINITEST HCG PREGNANCY TEST
BAYER HEALTHCARE, LLC
BAYER CLINITEK STATUS ANALYZER
BAYER HEALTHCARE, LLC
BAYER RAPIDLAB 1200 SYSTEM
BAYER HEALTHCARE, LLC
Applications#
GUDID#
Essure - Essure is a permanent Birth Control System. One Essure Replacement Kit containing one pouched disposable delivery system with a wound-down insert and a valved introducer.
2014-09-04
Essure - Essure is a permanent Birth Control System. One Essure pouched disposable delivery system with a wound-down insert and a valved introducer. Two Pouched Delivery Systems are contained in the Essure Kit and are not sold separately.
2014-09-04
Essure - Essure is a permanent Birth Control System. Each Essure Kit is comprised of two pouched disposable delivery systems with a wound-down insert and a valved introducer.
2014-09-04
AVX - AVX CUS CATHETER, FG PKG
2014-10-09
XVG - XVG CUS CATHETER, FG PKG
2014-10-09
SPIROFLEX VG - SPIROFLEX VG CUS CATH FG PKG
2014-10-07
SPIROFLEX - SPIROFLEX CUS CATH, FG PKG
2014-10-09
XMI - XMI CUS CATHETER, FG PKG
2014-10-07
SOLENT PROXI - SOLENT PROXI CATH, FG PKG
2014-10-09
SOLENT OMNI - SOLENT OMNI CATHETER, FG PKG
2014-10-07
FETCH 2 - F2 CATHETER FG PKG
2014-10-09
SOLENT DISTA - SOLENT DISTA, FG PKG
2014-10-09
DISTAFLEX - DISTA FLEX, FG PKG
2014-10-07
JETWIRE - JETSTREAM GUIDEWIRE
2015-02-27
Dr. Scholl's - Dr. Scholl's Dual Action Freeze Away Wart Remover provides convenient home use treatment for noncancerous, yet contagious plantar and common warts. It is a combination of freezing and liquid ( acid) treatment of the wart. It consists of the following: pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 7 disposable applicators, 9.8ml liquid wart remover, 9 cover- up cushions, and information booklet.
2016-09-01
Dr. Scholl's - Dr. Scholl's Freeze Away Wart Remover ( blue Box) is a cryosurgical system for the removal of common and plantar warts. The device consists of the following: pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 7 disposable applicators and information booklet.
2016-09-01
Dr. Scholl's - Dr. Scholl's Freeze Away Wart Remover ( Yellow Box) is a cryosurgical system for the removal of common and plantar warts. The device consists of the following: Pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 7 disposable applicators and information booklet.
2016-09-01
Dr. Scholl's - Dr. Scholl's Freeze Away Wart Remover ( blue Box) is a cryosurgical system for the removal of common and plantar warts. The device consists of the following: pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 12 disposable applicators and information booklet.
2018-02-12
Dr. Scholl's - Dr. Scholl's Dual Action Freeze Away Wart Remover provides convenient home use treatment for noncancerous, yet contagious plantar and common warts. It is a combination of freezing and liquid ( acid) treatment of the wart. It consists of the following: pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 7 disposable applicators, 9.8ml liquid wart remover, 9 cover- up cushions, and information booklet.
2016-09-01
Aleve - Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, physical therapists, and chiropractor's offices. Aleve Direct Therapy TENS Device is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The kit contains a device, 2 pairs of gel pads, 2-AAA batteries, 1 Phillips head screwdriver and a wireless remote control.
2017-09-01
Aleve - Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, physical therapists, and chiropractor's offices. Aleve Direct Therapy TENS Device is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The kit contains a device, 1 pair of gel pads, 2-AAA batteries, 1 Phillips head screwdriver and a wireless remote control.
2016-09-01
Aleve - Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, physical therapists, and chiropractor's offices. Aleve Direct Therapy TENS Device is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The kit contains a device, 2 pairs of gel pads, 2-AAA batteries, 1 Phillips head screwdriver and a wireless remote control.
2017-09-01
Aleve - 2 pairs of Aleve Direct Therapy TENs Device Refill Gel Pads packaged in one re-sealable pouch.
2016-09-01
Aleve - Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, physical therapists, and chiropractor's offices. Aleve Direct Therapy TENS Device is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The kit contains a device, 1 pair of gel pads, 2-AAA batteries, 1 Phillips head screwdriver and a wireless remote control.
2016-09-01
POWER PULSE - PPS ANCILLARY PACK, FG PKG
2014-10-09
Dr. Scholl's - Dr. Scholl's Freeze Away Wart Remover ( blue Box) is a cryosurgical system for the removal of common and plantar warts. The device consists of the following: pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 7 disposable applicators and information booklet.
2016-09-01
Dr. Scholl's - Dr. Scholl's Freeze Away Wart Remover ( Yellow Box) is a cryosurgical system for the removal of common and plantar warts. The device consists of the following: Pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 7 disposable applicators and information booklet.
2016-09-01
ANGIOJET - ULTRA SYSTEM CONSOLE, FG
2014-10-09
JETSTREAM - JETSTREAM CONSOLE
2014-12-01
JETSTREAM SC - JETSTREAM SC 1.6MM, FG PKG
2014-10-09
JETSTREAM SC - JETSTREAM SC 1.85MM, FG PKG
2014-10-09
JETSTREAM XC - JETSTREAM XC 2.1 MM, FG PKG
2014-10-09
JETSTREAM XC - JETSTREAM XC 2.4MM, FG PKG
2014-10-09