MAX-100

GUDID B641MAX1004

Metered-delivery hypodermic syringe

Primary Device ID	B641MAX1004
NIH Device Record Key	97c3ccf5-3736-405c-8394-eb6c89d5a074
Commercial Distribution Status	In Commercial Distribution
Brand Name	MAX-100
Version Model Number	MAX-100 Syringe
Company DUNS	790888833
Company Name	DAXOR CORPORATION
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
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

Device Issuing Agency	Device ID
HIBCC	B641MAX1000 [Primary]
HIBCC	B641MAX1001 [Package] Contains: B641MAX1000 Package: Tyvek Pouch [5 Units] In Commercial Distribution
HIBCC	B641MAX1002 [Package] Contains: B641MAX1000 Package: Tyvek Pouch [10 Units] In Commercial Distribution
HIBCC	B641MAX1003 [Package] Contains: B641MAX1001 Package: Corrugated Box [250 Units] In Commercial Distribution
HIBCC	B641MAX1004 [Package] Contains: B641MAX1002 Package: Corrugated Box [250 Units] In Commercial Distribution
HIBCC	B641MAX1005 [Package] Contains: B641MAX1000 Package: Corrugated Box [200 Units] In Commercial Distribution

FMF	Syringe, Piston

Steralize Prior To Use	false
Device Is Sterile	true

B641MAX1004	Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin inject
B641MAX10055	Sterile Syringe delivery device used to deliver (inject) Volumex (I-131 HSA) for use in determin

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