FDA UDI
In Commercial Distribution
🇺🇸 United States
Bar Code Reader Kit
DI: B365503720
·
Model: 50-372
·
Aktina Corp.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Bar Code Reader Kit
- Primary DI
- B365503720
- Version / Model
- 50-372
- Company Name
- Aktina Corp.
- Labeler DUNS
- 787178920
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-21
- Public Version
- 2
- Public Version Date
- 2022-05-11
- Public Version Status
- Update
- Public Device Record Key
- c561cc06-0157-4941-827b-077b697f2443
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37035 | Barcode reader | A device that reads and interprets barcodes of various format. A barcode is typically an electronically readable information strip consisting of parallel, vertical stripes and spaces of variable thicknesses which can also be presented in two or more layered information levels. This device may have the capability of storing the read data and downloading this into other data systems when this is required. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B365503720 | HIBCC | ||||
| Secondary | 00810110900417 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161984 | 000 |