FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 04037691123820
·
Model: Ven.Cath.,2-stage,reinf.,ell.,Light.tip
·
Maquet Cardiopulmonary AG
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04037691123820
- Version / Model
- Ven.Cath.,2-stage,reinf.,ell.,Light.tip
- Catalog Number
- 70101.4232
- Company Name
- Maquet Cardiopulmonary AG
- Labeler DUNS
- 316153865
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 6
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- 66626b46-6b83-44c8-bdf7-2cab48083bc1
- Distribution End Date
- 2020-01-31
Device Description
Venous Catheter, two-stage, SLIM, complete reinforcement, elliptic proximal body, Lighthouse tip, with connector
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 |
|---|---|---|---|---|
| DTL | Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass | Cardiovascular | 870.4290 | 2 |
| DWF | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34905 | Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous | A semi-rigid or rigid tube intended to be surgically inserted into the right atrium or large vein to serve as a channel for the extracorporeal transport of deoxygenated blood from 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 |
|---|---|---|---|---|---|---|
| Package | 04037691223155 | GS1 | 10 | Not in Commercial Distribution | 2020-01-31 | |
| Primary | 04037691123820 | GS1 |
Customer Contacts
- Phone
- +49072229320
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013944 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Outer Diameter 36/48 French | ||
| Device Size Text, specify | Connector 1/2 Inch | ||
| Length | 40 | Centimeter |