FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Edwards Lifesciences Arterial Perfusion Cannula
DI: 00690103026375
·
Model: APC022B
·
Edwards Lifesciences LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Edwards Lifesciences Arterial Perfusion Cannula
- Primary DI
- 00690103026375
- Version / Model
- APC022B
- Catalog Number
- APC022B
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- 4129e407-3afd-4c33-94d9-06538cd263ae
- Distribution End Date
- 2017-12-31
Device Description
Arterial Perfusion Cannula
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 |
|---|---|---|---|---|
| DQR | CANNULA, CATHETER | Cardiovascular | 870.1300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34893 | Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial | A semi-rigid or rigid tube intended to be surgically inserted into an artery to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690103026375 | GS1 | ||||
| Package | 50690103026370 | GS1 | Shipper | 10 | Not in Commercial Distribution | 2017-12-31 |
Customer Contacts
- Phone
- +1(800)822-9637
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K894243 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 22 Fr. (7.3 mm) x 15 cm (6") |