FDA UDI
In Commercial Distribution
🇺🇸 United States
ViaMed
DI: 00811382011504
·
Model: 13410-BLUE
·
RECE INTERNATIONAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- ViaMed
- Primary DI
- 00811382011504
- Version / Model
- 13410-BLUE
- Company Name
- RECE INTERNATIONAL CORPORATION
- Labeler DUNS
- 787828537
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-12-04
- Public Version
- 1
- Public Version Date
- 2020-12-14
- Public Version Status
- New
- Public Device Record Key
- 5012f078-bc59-4213-aeb8-5a54a9f1eef8
Device Description
Chest piece with two functions. The binaural head frame is made seamless brass tubes. Thick walled 22" PVC tubing, durable and noise proof. Comfortable smooth plastic ear plugs. Blue Color.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00811382011542 | GS1 | ||||
| Primary | 00811382011504 | GS1 |
Customer Contacts
- Phone
- 3053626555
- [email protected]