FDA UDI
In Commercial Distribution
🇺🇸 United States
Welch Allyn, Inc.
DI: 00732094309232
·
Model: 901057
·
WELCH ALLYN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
7
Pkg Device Count
1
Basic Information
- Brand Name
- Welch Allyn, Inc.
- Primary DI
- 00732094309232
- Version / Model
- 901057
- Catalog Number
- 44WT
- Company Name
- WELCH ALLYN, INC.
- Labeler DUNS
- 198227881
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-25
- Public Version
- 6
- Public Version Date
- 2022-06-28
- Public Version Status
- Update
- Public Device Record Key
- a1579164-060c-48b4-b5a9-68a9f77cd71c
Device Description
Spot 4400 with NIBP SureTemp and Nonin
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36872 | Multiple vital physiological parameter monitoring system, clinical | An assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00732094309409 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00732094309232 | GS1 | ||||
| Package | 00732094326741 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00732094309447 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00732094309454 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00732094309461 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00732094309393 | GS1 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(315)685-2834
- [email protected]