FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MCV Infant ECC Pack with QPiD
DI: 00607567205482
·
Model: BEQ-TOP 28901
·
DATASCOPE CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MCV Infant ECC Pack with QPiD
- Primary DI
- 00607567205482
- Version / Model
- BEQ-TOP 28901
- Catalog Number
- 701056771
- Company Name
- DATASCOPE CORP.
- Labeler DUNS
- 001660786
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-26
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- ea3752b6-88ec-465c-a3ff-041c69e74131
- Distribution End Date
- 2017-04-11
Device Description
701050970 BEQ-HMOD 30000-USA Pediatric Quadrox iD 701066544 BO-VHK 310000 Venous res Pediatric 701054444 Better Bladder 701020489 BEQ-RF32 RotaFLow 701045763 Gas Filter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWE | Tubing, Pump, Cardiopulmonary Bypass | Cardiovascular | 870.4390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46838 | Cardiopulmonary bypass system, non-roller type | An assembly of devices that provides mechanical circulatory support during open-heart surgery, bypassing the heart to facilitate surgery on the organ. The basic function of the machine is to oxygenate the body's venous supply of blood and then pump it back into the arterial circuit. It will typically provide features such as intracardiac suction, filtration, and temperature control. This device typically consists of mains electricity (AC-powered) console with centrifugal blood pumps, oxygenators, a heat exchanger, temperature regulators, a reservoir, filters, and a defoamer. Some systems are manufactured as a single unit while others are made up of modules. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00607567205482 | GS1 |
Customer Contacts
- Phone
- 18886278383
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius