FDA UDI
In Commercial Distribution
🇺🇸 United States
Welch Allyn, Inc.
DI: 00732094356861
·
Model: 901143
·
WELCH ALLYN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Welch Allyn, Inc.
- Primary DI
- 00732094356861
- Version / Model
- 901143
- Catalog Number
- 109203
- Company Name
- WELCH ALLYN, INC.
- Labeler DUNS
- 198227881
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-18
- Public Version
- 1
- Public Version Date
- 2024-12-26
- Public Version Status
- New
- Public Device Record Key
- a332b06d-0114-41ef-a972-7173d54afa7d
Device Description
DVD SOFTWARE VISION V6.4.1
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| MLO | ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM | Cardiovascular | 870.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41651 | Electrocardiographic long-term ambulatory recording analyser application software | A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00732094356861 | GS1 |
Customer Contacts
- Phone
- +1(315)685-2834
- [email protected]