FDA UDI
In Commercial Distribution
🇺🇸 United States
MULTIFLOW
DI: 00849593015585
·
Model: SM-602353
·
Advantage Medical Electronics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MULTIFLOW
- Primary DI
- 00849593015585
- Version / Model
- SM-602353
- Company Name
- Advantage Medical Electronics, LLC
- Labeler DUNS
- 080242300
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-03
- Public Version
- 2
- Public Version Date
- 2023-02-10
- Public Version Status
- Update
- Public Device Record Key
- 5f357ee0-2dfb-41cc-b457-da8244aa6a6b
Device Description
DUAL NO CASING RESP. MONITOR
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | Anesthesiology | 868.2375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36548 | Patient monitoring system module, electrocardiographic/respiratory | A small unit dedicated to the measurement of the electrical activity of the heart in the form of an electrocardiogram (ECG) and to follow patient respiration patterns to identify episodes of arrhythmia and/or apnoea also derived from the ECG. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the electrocardiographic/respiratory information. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849593015585 | GS1 |
Customer Contacts
- Phone
- 954-345-9800
- [email protected]