FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 00888499001964
·
Model: SMS12ARD
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 00888499001964
- Version / Model
- SMS12ARD
- Catalog Number
- SMS12ARD
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-27
- Public Version
- 3
- Public Version Date
- 2020-04-29
- Public Version Status
- Update
- Public Device Record Key
- de9d0ba5-4814-4b4e-aec0-23e59be990d3
Device Description
Stethoscopes; Adult; Single Head; Red
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
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LDE | STETHOSCOPE, MANUAL | Cardiovascular | 870.1875 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13755 | Mechanical stethoscope | A mechanical listening device designed for listening to sounds from the heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the users ears. Mechanical stethoscopes are typically found in two variants 1) a general-purpose stethoscope used for clinical/ward activities; or 2) a reinforced stethoscope used by cardiologists. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10888499001961 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 00888499001964 | GS1 | ||||
| Package | 20888499001968 | GS1 | CASE | 10 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- High: 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius