FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TandemHeart
DI: 00814112020104
·
Model: 5130-1717
·
CARDIACASSIST, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TandemHeart
- Primary DI
- 00814112020104
- Version / Model
- 5130-1717
- Catalog Number
- 5130-1717
- Company Name
- CARDIACASSIST, INC.
- Labeler DUNS
- 948683941
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-10
- Public Version
- 8
- Public Version Date
- 2025-08-26
- Public Version Status
- Update
- Public Device Record Key
- 1312728b-1757-4200-9ae2-a3aa25c0325f
- Distribution End Date
- 2025-01-14
Device Description
17 Fr x 17 cm femoral arterial cannula with 12 Fr Introducer
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
- 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 |
|---|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | 870.4210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34893 | Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return | A semi-rigid or rigid tube intended to be surgically inserted into an artery or vein to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as an arterial cannula. 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 | 00814112020104 | GS1 |
Customer Contacts
- Phone
- +14129637770
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius