FDA UDI
In Commercial Distribution
🇺🇸 United States
Multi-Link™
DI: 10889483578049
·
Model: 2090101-911
·
AirLife Finland Oy
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Multi-Link™
- Primary DI
- 10889483578049
- Version / Model
- 2090101-911
- Catalog Number
- 2090101-911
- Company Name
- AirLife Finland Oy
- Labeler DUNS
- 368457563
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-02
- Public Version
- 1
- Public Version Date
- 2025-04-10
- Public Version Status
- New
- Public Device Record Key
- 53accd87-6f84-448b-af23-5a633963bf71
Device Description
Multi-Link™ X2 Single-Patient-Use Direct-Connect ECG Leadwire Set 3-Lead Set for Dräger, Grabber, AHA
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| 61821 | Electrocardiographic lead set, single-use | A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20889483578046 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 10889483578049 | GS1 | ||||
| Previous | 10190752182783 | GS1 |
Customer Contacts
- Phone
- (800)433-2797
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163316 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -22 – 158 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 70 Degrees Celsius