bayer.comKovaltry
Antihemophilic Factor (Recombinant)
BAYER HEALTHCARE LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 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 |
|---|---|
| 200860 | 1509386015 |
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
Aleve Arthritis Pain Gel
Diclofenac Sodium
Aleve Headache Pain
Naproxen Sodium
AleveX
camphor and menthol
AleveX
camphor and menthol
AleveX
camphor and menthol
Alka-Seltzer Heartburn Relief Extra Strength
Anhydrous citric acid, Sodium bicarbonate (heat-treated)
Alka-Seltzer Heartburn Relief Lemon Lime
Anhydrous citric acid, Sodium bicarbonate (heat-treated)
Aleve liquid gels
Naproxen Sodium
Midol Complete
Midol Complete
Tinactin
Tolnaftate
Tinactin
Tolnaftate
Lotrimin
Clotrimazole
Afrin No Drip
Oxymetazoline hydrochloride
Afrin No-Drip
Oxymetazoline hydrochloride
Claritin
Loratadine
Claritin
Loratadine
PMN#
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
Bayer HealthCare LLC
CONTOUR NEXT EZ BLOOD GLUCOSE METER
BAYER HEALTHCARE LLC
CONTOUR NEXT BLOOD GLUCOSE METER
BAYER HEALTHCARE LLC
DIDGET WORLD REPORTS
BAYER HEALTHCARE LLC
ADVIA CHEMISTRY MICROALBUMIN CONTROLS
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