FDA UDI
In Commercial Distribution
🇺🇸 United States
Welch Allyn, Inc.
DI: 00732094335392
·
Model: 901058
·
WELCH ALLYN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
9
Pkg Device Count
1
Basic Information
- Brand Name
- Welch Allyn, Inc.
- Primary DI
- 00732094335392
- Version / Model
- 901058
- Catalog Number
- 75RT
- Company Name
- WELCH ALLYN, INC.
- Labeler DUNS
- 198227881
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-03
- Public Version
- 1
- Public Version Date
- 2022-10-11
- Public Version Status
- New
- Public Device Record Key
- d55a78f8-2728-4ee1-a908-ec9f86b6b9a5
Device Description
WIFI CSM NIBP Mas RRp SureTemp
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57962 | Prostate electrolytic therapy system | A mobile assembly of mains electricity (AC-powered) devices designed to treat benign prostatic hyperplasia (BPH) and prostatitis through transurethral electrochemical treatment causing liquefaction necrosis to the diseased peri-urethral prostate. It typically consists of a power supply that provides a low output level (e.g., less than 30 volts) and an adjustable output current [e.g., 0 to 100 milliampere (mA)], operator's console, monitoring systems, alarms, software, and an electrolytic therapeutic catheter. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00732094335538 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00732094335392 | GS1 | ||||
| Package | 00732094335552 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00732094335521 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00732094335514 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00732094335545 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00732094335507 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00732094335569 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00732094335576 | GS1 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(315)685-2834
- [email protected]