FDA UDI
In Commercial Distribution
🇺🇸 United States
Rolling stand(BeneVision N19/N22)
DI: 06944904091716
·
Model: 045-003133-00
·
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rolling stand(BeneVision N19/N22)
- Primary DI
- 06944904091716
- Version / Model
- 045-003133-00
- Company Name
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Labeler DUNS
- 654671304
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-13
- Public Version
- 1
- Public Version Date
- 2020-05-21
- Public Version Status
- New
- Public Device Record Key
- 25d369d2-8e62-4214-9e46-7e7660c5ed82
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
- No
- 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 |
|---|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35586 | Hand rail | A device that is fixed to the wall and is of differing bar shaped designs that is intended to provide a person with a disability a supportive hand-hold whilst standing and moving. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06944904091716 | GS1 |
Customer Contacts
- Phone
- +8675581888998
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182075 | 000 |