FDA UDI
In Commercial Distribution
🇺🇸 United States
MAX-100
DI: B641MAX1000
·
Model: MAX-100 Syringe
·
DAXOR CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
1
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Basic Information
- Brand Name
- MAX-100
- Primary DI
- B641MAX1000
- Version / Model
- MAX-100 Syringe
- Company Name
- DAXOR CORPORATION
- Labeler DUNS
- 790888833
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-21
- Public Version
- 3
- Public Version Date
- 2025-08-22
- Public Version Status
- Update
- Public Device Record Key
- 97c3ccf5-3736-405c-8394-eb6c89d5a074
Device Description
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
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B641MAX1004 | HIBCC | Corrugated Box | 250 | Not in Commercial Distribution | 2020-09-15 |
| Package | B641MAX1002 | HIBCC | Tyvek Pouch | 10 | Not in Commercial Distribution | 2020-09-15 |
| Primary | B641MAX1000 | HIBCC | ||||
| Package | B641MAX1003 | HIBCC | Corrugated Box | 250 | Not in Commercial Distribution | 2020-09-15 |
| Package | B641MAX1001 | HIBCC | Tyvek Pouch | 5 | In Commercial Distribution | |
| Package | B641MAX1005 | HIBCC | Corrugated Box | 200 | Not in Commercial Distribution | 2025-08-21 |
Customer Contacts
- Phone
- 8654250555
- [email protected]