FDA UDI
In Commercial Distribution
🇺🇸 United States
Iradimed
DI: 00856038001225
·
Model: 3886
·
IRADIMED CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Iradimed
- Primary DI
- 00856038001225
- Version / Model
- 3886
- Catalog Number
- 3886
- Company Name
- IRADIMED CORP.
- Labeler DUNS
- 170301969
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-17
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- ab30792d-1d4b-45ad-bf1e-3cf34919a258
Device Description
MRI Wireless Multi-Gas Unit w/O2
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 Conditional
- 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 |
|---|---|---|---|---|
| MWI | Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 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 | 00856038001225 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172200 | 000 |