FDA UDI
In Commercial Distribution
🇺🇸 United States
Three vaporizer mount
DI: 06944904086828
·
Model: 115-020218-00
·
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Three vaporizer mount
- Primary DI
- 06944904086828
- Version / Model
- 115-020218-00
- 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
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- acd5c72c-e230-442a-8093-cfc2b5d1e8a2
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
- 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 |
|---|---|---|---|---|
| BSZ | Gas-machine, anesthesia | Anesthesiology | 868.5160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47770 | Anaesthesia unit, wall-mounted | An assembly of devices mounted on a framework and wall-mounted (static and typically hung on a medical device service rail system) designed to continuously or intermittently administer and monitor a mixture of gases [oxygen (O2), nitrous oxide (N2O), medical air, and anaesthetic agents] to provide a patient with an appropriate level of anaesthesia for a surgical procedure. It typically includes mechanical gas-delivery devices (e.g., flowmeters and vaporizers) and connects directly into the gas terminal units; it typically incorporates a patient breathing circuit and basic gas monitoring devices. The device is most often used in induction rooms and facilities for minor/short-stay surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06944904086828 | GS1 |
Customer Contacts
- Phone
- +8675581888998
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151954 | 000 |