SecureFoam™ Medium BKRT-5037

GUDID 10714646000382

SecureFoam. Medium, Component B

Bionix, LLC

Radiological whole-body positioner
Primary Device ID10714646000382
NIH Device Record Key6a20f8ee-0548-4f7c-92b9-7b4c7e16084c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSecureFoam™ Medium
Version Model NumberBKRT-5037
Catalog NumberBKRT-5037
Company DUNS117844489
Company NameBionix, LLC
Device Count10
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.

Device Identifiers

Device Issuing AgencyDevice ID
GS100714646000385 [Primary]
GS110714646000382 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-16
Device Publish Date2022-08-08

On-Brand Devices [SecureFoam™ Medium]

10714646000382SecureFoam. Medium, Component B
10714646000375SecureFoam, Medium, Component A

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