FDA UDI
In Commercial Distribution
🇺🇸 United States
TEMPO AQUA
DI: 20705032009079
·
Model: 452543S0
·
CORDIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TEMPO AQUA
- Primary DI
- 20705032009079
- Version / Model
- 452543S0
- Catalog Number
- 452543S0
- Company Name
- CORDIS CORPORATION
- Labeler DUNS
- 806136177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 6
- Public Version Date
- 2022-08-10
- Public Version Status
- Update
- Public Device Record Key
- 1f966e9e-be7b-46b7-9eb6-ad76cfc9ca77
Device Description
CATH TEMPO AQUA 5F C2 80CM
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | Cardiovascular | 870.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10688 | Angiographic catheter, single-use | A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20705032009079 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K000579 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damanged
- Type
- Special Storage Condition, Specify
- Special Conditions
- To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter
- Type
- Special Storage Condition, Specify
- Special Conditions
- Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dark, dry place