FDA UDI
Not in Commercial Distribution
🇺🇸 United States
System M ®
DI: 05060434420176
·
Model: Gas Module
·
SPECTRUM MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- System M ®
- Primary DI
- 05060434420176
- Version / Model
- Gas Module
- Catalog Number
- 3003-030-013
- Company Name
- SPECTRUM MEDICAL LIMITED
- Labeler DUNS
- 516398679
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2025-06-19
- Public Version Status
- Update
- Public Device Record Key
- 2f851fc0-7baa-4440-a86f-f8c26fa8afa6
- Distribution End Date
- 2017-01-01
Device Description
Ultra Low Flow - (0.05 - 0.5 L/min)
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | Cardiovascular | 870.4330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37238 | Extracorporeal blood gas/pH monitor | A mains electricity (AC-powered) device designed for the continuous measurement and display of blood gas and related parameters when blood is circulated outside of the body in a closed system. It is typically used with an appropriate sensor or sensor cassette inserted into external tubing to measure parameters such as partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, temperature, haemoglobin (Hb), and hematocrit (Hct). It is typically used with a cardiopulmonary bypass system, or bedside for a patient with respiratory failure (e.g., obstructive lung disease, severe asthma) or severe pulmonary hypertension after cardiac surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060434420176 | GS1 |
Customer Contacts
- Phone
- +441242650120
- [email protected]
- Phone
- 800 265 2331
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110957 | 000 |