FDA UDI
In Commercial Distribution
🇺🇸 United States
2-Slot AG/O2 Module
DI: 06936415919085
·
Model: 115-056533-00
·
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 2-Slot AG/O2 Module
- Primary DI
- 06936415919085
- Version / Model
- 115-056533-00
- 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
- 2020-05-12
- Public Version
- 1
- Public Version Date
- 2020-05-20
- Public Version Status
- New
- Public Device Record Key
- 222d2c66-acd3-4944-9799-9420db358c36
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 |
|---|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | Anesthesiology | 868.5160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47769 | Anaesthesia unit, mobile | A stand-alone assembly of devices on wheels for mobility designed to continuously or intermittently administer a mixture of gases [e.g., oxygen (O2), ambient/medical air, nitrous oxide (N2O), anaesthetic agents] to provide a patient with an appropriate level of anaesthesia for a surgical procedure. Also known as an anaesthesia machine, it may include an oxygen concentrator or function with mounted medical gas cylinders, and typically has mechanical gas-delivery devices (e.g., flowmeters and vaporizers). It may incorporate a powered or manual anaesthesia ventilator, a patient breathing circuit, and gas monitoring devices; patient monitors are typically separately mounted (not integral). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06936415919085 | GS1 |
Customer Contacts
- Phone
- +8675581888998
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182075 | 000 |