FDA UDI
In Commercial Distribution
🇺🇸 United States
ARROW
DI: 00801902098184
·
Model: IPN032666
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ARROW
- Primary DI
- 00801902098184
- Version / Model
- IPN032666
- Catalog Number
- AR-14703
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 9
- Public Version Date
- 2023-07-18
- Public Version Status
- Update
- Public Device Record Key
- 8adb3d27-bce9-49d4-8b87-db0016d96922
Device Description
Pressure Transduction Probe for use in conjunction with Arrow(R) Raulerson Spring-Wire Introduction Syringe
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQX | WIRE, GUIDE, CATHETER | Cardiovascular | 870.1330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63444 | Percutaneous pressure probe | A non-dedicated, electronic, invasive device intended to be introduced percutaneously for measurement of a variety of patient physiological pressures (e.g., compartmental pressure, intradiscal pressure). It consists of a needle-like tip containing a pressure transducer, and a cable intended to be connected to an appropriate monitor to allow readings to be displayed and/or recorded. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20801902098188 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 00801902098184 | GS1 | ||||
| Package | 30801902098185 | GS1 | Case | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]