FDA UDI
In Commercial Distribution
🇺🇸 United States
Captus 4000e Thyroid Uptake System with Well
DI: 00859942006102
·
Model: Captus 4000e Thyroid System with Well
·
Mirion Technologies (capintec), Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Captus 4000e Thyroid Uptake System with Well
- Primary DI
- 00859942006102
- Version / Model
- Captus 4000e Thyroid System with Well
- Catalog Number
- 5430-30152
- Company Name
- Mirion Technologies (capintec), Inc.
- Labeler DUNS
- 047684501
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-11
- Public Version
- 2
- Public Version Date
- 2022-12-14
- Public Version Status
- Update
- Public Device Record Key
- 528e5b6a-38fe-4abe-98db-c17e167d0a12
Device Description
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, Bioassay module, Wipe Test Module, and Lab Tests.
Device Characteristics
- Single Use
- No
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IZD | Probe, Uptake, Nuclear | Radiology | 892.1320 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40648 | Thyroid-uptake nuclear medicine system | An assembly of diagnostic devices that comprise a non-imaging nuclear medicine system designed primarily for radioactive iodine related thyroid uptake measurement and analysis applications. It can typically be upgraded with the addition of software and hardware for use in various quality assurance (QA) or radioimmunoassay laboratory applications, e.g., wipe-test assessment or Schilling tests. It typically includes a multichannel analyser, computer, scintillation detector, detector support equipment, an operator's console, video display, well counter detector, collimator, shielding, and application software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859942006102 | GS1 |
Customer Contacts
- Phone
- 201-825-9500
- [email protected]