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Lithium Manganese Dioxide battery for replacement in Philips(TM) Heartstart(TM) FRx Onsite & Home(TM).
AED BATTERY EXCHANGE, LLC
5070-ABE
In Commercial Distribution
- 00864312000208 ()
- Primary battery
Exhaust Collection Bag, S1 (single bag in pouch with IFU), accessory to Cerene Cryotherapy Device
CHANNEL MEDSYSTEMS, INC.
FGS-7015
In Commercial Distribution
- 00850008595042 ()
- General cryosurgical system, cryogen gas, electronic
Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder.
SENSEONICS, INCORPORATED
FG-7202-00-301
In Commercial Distribution
- 00817491022974 ()
FG-7202-00-301
- Implantable glucose monitoring system sensor
Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder.
SENSEONICS, INCORPORATED
FG-7201-00-301
In Commercial Distribution
- 00817491022967 ()
FG-7201-00-301
- Implantable glucose monitoring system sensor
Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder.
SENSEONICS, INCORPORATED
FG-7200-00-301
In Commercial Distribution
- 00817491022950 ()
FG-7200-00-301
- Implantable glucose monitoring system sensor
Single Patient Use Filshie® Clip Applicator System. Applicator for use ONLY in Sterishot Kits.
FEMCARE LIMITED
AVM-600
In Commercial Distribution
- 15055515602326 ()
AVM-600
- Fallopian tube clip/band
The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.
Beckman Coulter, Inc.
37200
In Commercial Distribution
- H628372001 ()
37200
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.
Beckman Coulter, Inc.
C22845
In Commercial Distribution
- 15099590701673 ()
C22845
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Indications for FH:
The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma.
Indications for FSGS:
The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
KP-05
In Commercial Distribution
- 14537693900636 ()
- 04537693900639 ()
- Apheresis system filter, whole blood
Indications for FH:
The Apheresis Machine KANEKA MA-03 is components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma.
Indications for FSGS:
The Apheresis Machine KANEKA MA-03 is components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
KANEKA MA-03
In Commercial Distribution
- 04987671040374 ()
- Apheresis system