FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 20193489139652
·
Model: MDSLRT38
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Medline
- Primary DI
- 20193489139652
- Version / Model
- MDSLRT38
- Catalog Number
- MDSLRT38
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-06-08
- Public Version
- 2
- Public Version Date
- 2024-06-06
- Public Version Status
- Update
- Public Device Record Key
- a4ee7d0c-1116-4936-9680-646987d99547
Device Description
ELECTRODE,ECG,TAB,10/CARD,5000/CS, SMALL
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRX | Electrode, electrocardiograph | Cardiovascular | 870.2360 | 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 | 40193489139656 | GS1 | CASE | 50 | In Commercial Distribution | |
| Package | 30193489139659 | GS1 | BOX | 5 | In Commercial Distribution | |
| Primary | 20193489139652 | GS1 | ||||
| Unit of Use | 10193489139655 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight. Protect from freezing, avoid excessive heat. Keep dry
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius