FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Scio Four, plus
DI: 04048675429319
·
Model: 6871802
·
Drägerwerk AG & Co. KGaA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Scio Four, plus
- Primary DI
- 04048675429319
- Version / Model
- 6871802
- Company Name
- Drägerwerk AG & Co. KGaA
- Labeler DUNS
- 315578914
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-11-04
- Public Version
- 5
- Public Version Date
- 2026-02-06
- Public Version Status
- Update
- Public Device Record Key
- 946d605e-1787-4c97-8f86-335f34052aa0
- Distribution End Date
- 2024-08-01
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36028 | Anaesthetic agent gas monitor, multiple | A mains electricity (AC-powered) instrument designed for the continuous and simultaneous sampling, measuring, and display of concentrations of more than one gaseous anaesthetic agent (e.g., halothane, desflurane, Ethrane, isoflurane) in a breathing system (e.g., at an anaesthetic unit/workstation outlet or from a bedside breathing/sampling system), to ensure that appropriate agent levels are administered to a patient. It may also measure inspired and/or expired oxygen (O2) and/or carbon dioxide (CO2). Methods to determine gas concentrations include infrared (IR) spectrometry, ultraviolet (UV) absorption, interferometry, and ultrasound. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048675429319 | GS1 |
Customer Contacts
- Phone
- +494518820
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051628 | 000 |