FDA UDI
In Commercial Distribution
🇺🇸 United States
Vital Signs™
DI: 10889483582114
·
Model: 406551-033
·
AirLife Finland Oy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Vital Signs™
- Primary DI
- 10889483582114
- Version / Model
- 406551-033
- Catalog Number
- 406551-033
- Company Name
- AirLife Finland Oy
- Labeler DUNS
- 368457563
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-31
- Public Version
- 1
- Public Version Date
- 2025-04-08
- Public Version Status
- New
- Public Device Record Key
- 1da2b251-6116-4d01-a19f-5f92e2bed54f
Device Description
Vital Signs™ ECG Connector for CAM14 Mactrode™ V3R Gray AHA
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
- Yes
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | 870.2900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60635 | Electrocardiographic electrode connector | A small clip designed to enable an electrical connection between an electrocardiographic electrode and an electrocardiographic lead wire. It is typically made of plastic materials, with a metallic part to provide electrical connection, and can be manually applied to a dedicated area of a disk-like electrode that is placed on the patient’s skin, with a socket at the other end for a plug on the lead. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10889483582114 | GS1 | ||||
| Previous | 10190752180086 | GS1 |
Customer Contacts
- Phone
- (800)433-2797
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082851 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -22 – 140 Degrees Fahrenheit