FDA UDI
In Commercial Distribution
🇺🇸 United States
Isansys
DI: 05060488680250
·
Model: Patient Gateway T510 - 10.1 - WiFi
·
ISANSYS LIFECARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Isansys
- Primary DI
- 05060488680250
- Version / Model
- Patient Gateway T510 - 10.1 - WiFi
- Catalog Number
- Gateway T510 - 10.1 - WiFi
- Company Name
- ISANSYS LIFECARE LIMITED
- Labeler DUNS
- 216707432
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-25
- Public Version
- 1
- Public Version Date
- 2024-05-03
- Public Version Status
- New
- Public Device Record Key
- bbe80ebd-8468-496e-8166-24341ac4ae0c
Device Description
Data entry & local display point tablet computer, 10.1 Screen
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Cardiovascular | 870.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64902 | Physiological measuring device wireless data capture/transfer unit | A mobile electronic device/device assembly designed to be used by a healthcare professional (e.g., nurse, caregiver) to capture patient physiological parameters from wireless patient measuring devices (e.g., wireless pulse oximeter, wireless thermometer) during routine patient checks (e.g., as part of nursing rounds) and wirelessly send the information to the electronic health record. It is intended to capture and transfer patient identification and time/date with the physiological data; it will typically in addition allow for manual entry of data. It typically includes a display monitor, wireless receivers, and barcode reader. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060488680250 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172329 | 000 |