PhotoFix N/A

GUDID B040PFP6X81

Cardiovascular patch, animal-derived

Primary Device ID	B040PFP6X81
NIH Device Record Key	73869f95-0ea8-41ce-a380-3941cdca297c
Commercial Distribution Status	In Commercial Distribution
Brand Name	PhotoFix
Version Model Number	PFP6x8
Catalog Number	N/A
Company DUNS	939872651
Company Name	GENESEE BIOMEDICAL, INC.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	true
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Storage Environment Temperature	Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Issuing Agency	Device ID
HIBCC	B040PFP6X81 [Primary]

DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Steralize Prior To Use	false
Device Is Sterile	true

B040ATR1 - AVATR Minimally Invasive Adult Retractor with Interchangeable Blades	2024-09-05 Multipurpose retractor for minimally invasive use - Thorocotomy, Sternotomy,
B040ATRAR0 - AVATR Minimally Invasive Adult Retractor with atrial and aortic rakes	2024-09-05 Multipurpose retractor for minimally invasive use with atrial and aortic rakes - Thorocotomy, Sternotomy,
B040CSR1 - Child Curved Sternal Retractor with Blades Only	2024-09-05 Child Curved Sternal Latch Retractor with 2 sets of Blades: Suitable for patients weighing from 15 to 45kg
B040CSRAR0 - Child Curved Sternal Retractor with Blades Only	2024-09-05 Child Curved Sternal Latch Retractor with atrial and aortic rakes: Suitable for patients weighing from 15 to 45 kg
B040MMX1 - MINIMAX Minimally Invasive Retractor	2024-09-05 Multipurpose retractor for minimally invasive thoracic use
B040MMX1R0 - MINIMAX Minimally Invasive Retractor	2024-09-05 Multipurpose retractor for minimally invasive thoracic use including radiolucent blades
B040NSR1 - Neonatal Curved Sternal Retractor with Blades Only	2024-09-05 Neonatal Curved Sternal Latch Retractor with 2 sets of Blades: Suitable for patients weighing from 0.5 to 5kg
B040NSRAR0 - Neonatal Curved Sternal Retractor with Blades Only	2024-09-05 Neonatal Curved Sternal Latch Retractor with atrial and aortic rakes: Suitable for patients weighing from 0.5 to 5kg

Mark Image Registration \| Serial	Company Trademark Application Date
PHOTOFIX 85491786 4752196 Live/Registered	CRYOLIFE, INC. 2011-12-09
PHOTOFIX 76544360 2907898 Dead/Cancelled	SORIN GROUP USA, INC. 2003-09-12
PHOTOFIX 75121606 2057445 Dead/Cancelled	Carbomedics, Inc. 1996-06-14
PHOTOFIX 74611043 2037597 Dead/Cancelled	LePixel 1994-12-14
PHOTOFIX 74306030 not registered Dead/Abandoned	CARBOMEDICS, INC. 1992-08-19