FDA UDI
In Commercial Distribution
🇺🇸 United States
Gas sampling line (M/M connectors) 3.5m
DI: 17325710009687
·
Model: 6887043
·
Maquet Critical Care AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Gas sampling line (M/M connectors) 3.5m
- Primary DI
- 17325710009687
- Version / Model
- 6887043
- Company Name
- Maquet Critical Care AB
- Labeler DUNS
- 632707092
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-05-27
- Public Version
- 1
- Public Version Date
- 2020-06-04
- Public Version Status
- New
- Public Device Record Key
- 7c3ceed4-e0c2-4598-9d6d-bf7bcaae5d03
Device Characteristics
- Single Use
- Yes
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 37710 | Anaesthesia workstation, general-purpose | An assembly of electronic devices used for general inhalation anaesthesia (i.e., the delivery of oxygen (O2), nitrous oxide (N2O), other medical gases, and anaesthetic agents) and possibly total intravenous anaesthesia and local anaesthesia. Its main components are high, intermediate, and low pressure gas delivery systems, a breathing circuit (typically with a ventilator), and an anaesthetic gas scavenging system (AGSS). It has built-in alarms, analysers, control/monitoring systems, and typically has integrated circuitry/touchscreen displays for target controlled anaesthesia (TCA) for any type of patient (e.g., neonate, adult). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17325710009687 | GS1 | ||||
| Unit of Use | 07325710009680 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191027 | 000 |