MAX-100

Primary DI
B641MAX1004
Brand
MAX-100
Company
DAXOR CORPORATION
Model
MAX-100 Syringe
Device description
Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin injection) for use in determinations of total blood and plas
Published
2018-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B641MAX1001PackageHIBCC5In Commercial Distribution
B641MAX1002PackageHIBCC10In Commercial Distribution
B641MAX1003PackageHIBCC250In Commercial Distribution
B641MAX1004PackageHIBCC250In Commercial Distribution
B641MAX1005PackageHIBCC200In Commercial Distribution
B641MAX1000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringeA sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
865-425-0555rdodgen@daxor.com
8654250555lcooper@daxor.com

Regulatory Flags#

DUNS number
790888833
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B641DAXBVA2Daxor BVABVA-2002025-09-05
B641MAX1000MAX-100MAX-100 Syringe2018-08-21
B641MAX10055MAX-100MAX-100 Syringe2020-09-30
B641CONVKIT1009BVA-100 Convenience Kit 9mlBVA-100 CONVKIT2023-07-24
B641BVA200BVA200CONVKITBVA200CONVKITBVA200CK2023-07-12
B641CONVKIT1000BVA-100 Convenience KitsBVA-100 CONVKIT2020-09-30
B641BVA100SOFTWARE60BVA100v6.0.4.2018-09-03
B641SC25MK20BVA100SC25 MK22018-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530753944FD-1017NS - 1ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951FD-1018NS - 1ml PC Syringe - Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217FD-1078NS 20ml PC Syringe - White Plunger - Saline PrintDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620FD-1048NS 10ml PC Syringe Yellow Plunger LidocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699FD-1075NS 10ml PC Syringe Light Blue Plunger XylocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941FD-1180NS 3ml Nugen Syringe Red PlungeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965FD-1162NS 10ml Nugen Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579FD-1029NS - 10ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593FD-1054NS - 10ml PC Syringe - Nitro Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753609FD-1039NS - 10ml PC Syringe - Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616FD-1071NS - 10ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623FD-1028NS - 10ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647FD-1072NS - 10ml PC Syringe Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654FD-1030NS - 10ml PC Syringe - Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661FD-1042NS - 10ml PC Syringe - Contrast Print - Light Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678FD-1044NS - 10ml PC Syringe - Contrast Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01