MAX-100

GUDID B641MAX1004

Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin injection) for use in determinations of total blood and plas

DAXOR CORPORATION

Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe
Primary Device IDB641MAX1004
NIH Device Record Key97c3ccf5-3736-405c-8394-eb6c89d5a074
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAX-100
Version Model NumberMAX-100 Syringe
Company DUNS790888833
Company NameDAXOR CORPORATION
Device Count1
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com
Phone865-425-0555
Emailrdodgen@daxor.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB641MAX1000 [Primary]
HIBCCB641MAX1001 [Package]
Contains: B641MAX1000
Package: Tyvek Pouch [5 Units]
In Commercial Distribution
HIBCCB641MAX1002 [Package]
Contains: B641MAX1000
Package: Tyvek Pouch [10 Units]
In Commercial Distribution
HIBCCB641MAX1003 [Package]
Contains: B641MAX1001
Package: Corrugated Box [250 Units]
In Commercial Distribution
HIBCCB641MAX1004 [Package]
Contains: B641MAX1002
Package: Corrugated Box [250 Units]
In Commercial Distribution
HIBCCB641MAX1005 [Package]
Contains: B641MAX1000
Package: Corrugated Box [200 Units]
In Commercial Distribution

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-21
Device Publish Date2018-08-21

On-Brand Devices [MAX-100]

B641MAX1004Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin inject
B641MAX10055Sterile Syringe delivery device used to deliver (inject) Volumex (I-131 HSA) for use in determin

Trademark Results [MAX-100]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MAX-100
MAX-100
74064176 1688354 Dead/Cancelled
JUSTIN INTERNATIONAL, INC.
1990-05-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.