FDA UDI
In Commercial Distribution
🇺🇸 United States
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
DI: 00690103197181
·
Model: XA3816SAFKT
·
Edwards Lifesciences LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
- Primary DI
- 00690103197181
- Version / Model
- XA3816SAFKT
- Catalog Number
- XA3816SAFKT
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 838a2e81-8ad9-488f-bf0e-e9a2c8226972
Device Description
EDWARDS OXIMETRY OLIGON CENTRAL VENOUS CATHETER KIT
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DQE | CATHETER, OXIMETER, FIBEROPTIC | Cardiovascular | 870.1230 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31659 | Oximeter catheter, single-use | A flexible tube containing a fibreoptic bundle designed to conduct light at a selected wavelength through blood to detect the reflected or scattered light for the estimation of blood oxygen concentration. It detects with a sensor at its distal end and is used in conjunction with an oximeter for oxygen concentration calculation. This device is also known as a Swan-Ganz catheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690103197181 | GS1 |
Customer Contacts
- Phone
- +1(800)822-9637
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160645 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | EXTERIOR DIAMETER: 8.5F (2.8MM), USABLE LENGTH: 16CM, NUMBER OF LUMENS: 3, MAXIMUM GUIDEWIRE DIAMETER: 0.032 IN (0.81 MM) |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE IN A COOL, DRY PLACE.