FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Nellcor
DI: 20884522042786
·
Model: MCU10-10
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Nellcor
- Primary DI
- 20884522042786
- Version / Model
- MCU10-10
- Catalog Number
- MCU10-10
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2019-12-06
- Public Version Status
- Update
- Public Device Record Key
- 7654135e-9051-437a-9924-fa0bdef1b32e
- Distribution End Date
- 2019-08-28
Device Description
Pulse Oximetry Interface Cable,Unterminated,Caution: For manufacturing, processing or repacking.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37178 | Transcutaneous blood gas monitor sensor | A device intended to be used with a transcutaneous blood gas monitor to measure a patient's blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), and/or blood oxygen saturation transcutaneously (through the skin). Gases diffuse through the skin and into this sensor at the skin surface, where it transmits electrical signals to the parent device for analysis. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10884522042789 | GS1 | CASE | 100 | Not in Commercial Distribution | 2019-08-28 |
| Primary | 20884522042786 | GS1 | ||||
| Unit of Use | 30884522042783 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K012891 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ;