FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Perfadex with THAM
DI: 07350069520050
·
Model: 19017
·
Xvivo Perfusion AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Perfadex with THAM
- Primary DI
- 07350069520050
- Version / Model
- 19017
- Catalog Number
- 19017
- Company Name
- Xvivo Perfusion AB
- Labeler DUNS
- 559895730
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-13
- Public Version
- 5
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- 39dbe32c-b8a1-45e6-a361-5b9f7fdf431a
- Distribution End Date
- 2017-12-31
Device Description
Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size: 8x 1000 ml
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| KDN | System, Perfusion, Kidney | Gastroenterology, Urology | 876.5880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18004 | Donor-organ/tissue/cell preservation solution | A solution intended to be used for the flushing, transport, storage and preservation of donor cells, tissues and/or organs (e.g., stem cells, skin, amniotic membrane, cardiovascular tissue, bone, tendon, kidney, liver, heart, pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain cell/tissue/organ viability until implantation in the recipient; some types may be combined with blood. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350069520050 | GS1 |
Customer Contacts
- Phone
- +13033959171
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius