FDA UDI
In Commercial Distribution
🇺🇸 United States
ProTube
DI: 07640172343005
·
Model: PTB
·
Inpeco SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ProTube
- Primary DI
- 07640172343005
- Version / Model
- PTB
- Company Name
- Inpeco SA
- Labeler DUNS
- 484880690
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-11
- Public Version
- 1
- Public Version Date
- 2020-09-21
- Public Version Status
- New
- Public Device Record Key
- e40cc2db-0b0c-4568-9b68-1ef6271706b3
Device Description
The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. The ProTube System is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers and sample check-out.
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 |
|---|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | Clinical Chemistry | 862.2100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64981 | Specimen information management system IVD | An assembly of hardware/software devices designed to manage specimen information, traceability and workflow within a laboratory environment. It typically consists of a data capture device [e.g., barcode reader or radio-frequency identification (RFID) scanner], touchscreen for data input and/or manipulation and a specimen container holder. It is intended to capture and transfer specimen information from the original specimen container to an assay container, which is subsequently fed into an analyser. The device does not perform specimen analysis, storage or data distribution functions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640172343005 | GS1 |