DEVICE: MAX-100 (B641MAX1000)
Device Identifier (DI) Information
MAX-100
MAX-100 Syringe
In Commercial Distribution
DAXOR CORPORATION
MAX-100 Syringe
In Commercial Distribution
DAXOR CORPORATION
Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin injection) for use in determinations of total blood and plasma volumes.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35904 | Metered-delivery hypodermic syringe |
A 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMF | Syringe, Piston |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
97c3ccf5-3736-405c-8394-eb6c89d5a074
September 16, 2020
2
August 21, 2018
September 16, 2020
2
August 21, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B641MAX1004 | 250 | B641MAX1002 | 2020-09-15 | Not in Commercial Distribution | Corrugated Box |
B641MAX1002 | 10 | B641MAX1000 | 2020-09-15 | Not in Commercial Distribution | Tyvek Pouch |
B641MAX1003 | 250 | B641MAX1001 | 2020-09-15 | Not in Commercial Distribution | Corrugated Box |
B641MAX1001 | 5 | B641MAX1000 | In Commercial Distribution | Tyvek Pouch | |
B641MAX1005 | 200 | B641MAX1000 | In Commercial Distribution | Corrugated Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
865-425-0555
rdodgen@daxor.com 8654250555
jadkins@daxor.com
rdodgen@daxor.com 8654250555
jadkins@daxor.com