FDA UDI
In Commercial Distribution
🇺🇸 United States
Welch Allyn, Inc.
DI: 00732094065152
·
Model: 901043
·
WELCH ALLYN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Welch Allyn, Inc.
- Primary DI
- 00732094065152
- Version / Model
- 901043
- Catalog Number
- REUSE-PED-HAND
- Company Name
- WELCH ALLYN, INC.
- Labeler DUNS
- 198227881
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 3
- Public Version Date
- 2019-07-22
- Public Version Status
- Update
- Public Device Record Key
- 4d200f4f-b664-438e-b8e6-0f6ebd34f98a
Device Description
Welch Allyn FlexiPort Blood Pressure Cuff; Four-Cuff Kit: Size-07 to Size-10; Reusable, 1-Tube (31.5 in/80.0 cm), Tri-Purpose (#5082-168) Connector; Qty. 4
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 |
|---|---|---|---|---|
| DXQ | blood pressure cuff | Cardiovascular | 870.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34978 | Blood pressure cuff, reusable | A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00732094065152 | GS1 |
Customer Contacts
- Phone
- +1(315)685-2834
- [email protected]