FDA UDI
In Commercial Distribution
🇺🇸 United States
IDENTIFY
DI: EHUQHQ0100707
·
Model: 1.7
·
humediQ global GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IDENTIFY
- Primary DI
- EHUQHQ0100707
- Version / Model
- 1.7
- Catalog Number
- HQ01007
- Company Name
- humediQ global GmbH
- Labeler DUNS
- 314128217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 05bea44b-7a91-47fa-a6f1-d2497afee1dc
Device Description
The intended use of the device is to identify the patient and patient specific accessories and to guide the positioning of patients and accessories for radiosurgery or radiotherapy prodedures. The only location where the device is used is the radiologic diagnostic and radiation therapy department.
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
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60473 | Radio-frequency identification patient positioning/tracking system application software | An application software program intended to be used with a radio-frequency identification patient positioning/tracking system. It is typically installed on an off-the-shelf computer and is used to integrate the components of the system, e.g., radio-frequency identification (RFID) tags and readers, optical/infrared cameras, and a hand-held control unit. It typically includes upgrades to the software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EHUQHQ0100707 | HIBCC |
Customer Contacts
- Phone
- +498964956284
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112692 | 000 |