FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04037691873077
·
Model: Holding Clamp; Oxygenator QUADROX-iR
·
Maquet Cardiopulmonary AG
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04037691873077
- Version / Model
- Holding Clamp; Oxygenator QUADROX-iR
- Catalog Number
- 70106.5923
- Company Name
- Maquet Cardiopulmonary AG
- Labeler DUNS
- 316153865
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e34465f9-f744-44cf-8bce-33a9ea5f40f9
Device Description
Holding Clamp for Oxygenator QUADROX-iR
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KFM | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | Cardiovascular | 870.4360 | 2 |
| DTM | Filter, blood, cardiopulmonary bypass, arterial line | Cardiovascular | 870.4260 | 2 |
| DTZ | OXYGENATOR, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4350 | 2 |
| DTR | HEAT-EXCHANGER, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4240 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43621 | Desk mount | A non-dedicated (general-purpose) manually-operated structure designed to be fixed to a desk or a worktop and onto which another medical device (not included) is intended to be safely affixed or mounted. This device is typically clamped (i.e., removable) or permanently screwed to the desk or a worktop surface. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04037691873077 | GS1 |
Customer Contacts
- Phone
- +49072229320
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133265 | 000 |