Central Venous Catheter Kit
- Primary DI
- 08886483506008
- Company
- BIOPTIMAL INTERNATIONAL PTE. LTD.
- Model
- CV-802-20
- Catalog number
- 25-000017-01
- Published
- 2023-10-31
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 595182247
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08886483506008 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 08886483506008 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | General Hospital | 880.5200 | N | Ineligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|
| Central venous catheterization kit, short-term | A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device. |
Device Sizes
No records found.
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store in dark cool dry places |
Contacts
No records found.
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|---|
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| 08886483501393 | Thermodilution Catheter and Accessories | TD2602NXF-MERIT(EUROPE) | 21-000151-12 | 2023-10-31 |
| 08886483501560 | Thermodilution Catheter and Accessories | TD2755NXF-MERIT(EUROPE) | 21-000202-02 | 2023-10-31 |
| 08886483501829 | BIOTRANS™ Pressure Monitoring Kits | PT24(BNS)-USA | 22-000074-10 | 2023-10-31 |
| 08886483502949 | BIOTRANS™ Pressure Monitoring Kits | MED-LOC LOCKING CANNULA-USA | 22-000895-55 | 2023-10-31 |
| 08886483505636 | Central Venous Catheter Kit | CV-501-16 | 25-000009-03 | 2023-10-31 |
| 08886483507524 | Embolectomy Catheter | EL3340 | EC-0001-003 | 2023-10-31 |
| 08886483508859 | Central Venous Catheter Kit | CV-713-16T | 24-000251-03 | 2023-10-31 |
| 08886483504257 | ACCUTRANS Disposable Pressure Monitoring Kit | AT 4812-3 - 22-000948-21 | 22-000948-21 | 2021-05-06 |
| 08886483508323 | BIOTRANS™ Pressure Monitoring Kits | BTR-4812-3 (CAT#5510219)-GE | 22-000813-30 | 2021-03-23 |
| 08886483508330 | BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables | BT-201 (CAT#5867983)-GE | BL-0003-021 | 2021-03-23 |
| 08886483500099 | Thermodilution Catheter and Accessories | TD2604NX (BNS)-CMS USA | 21-000009-41 | 2020-10-01 |
| 08886483500525 | Thermodilution Catheter and Accessories | TD2704NXF-BSI | 21-000048-77 | 2020-10-01 |
| 08886483500686 | Thermodilution Catheter and Accessories | TD2755NX-CCF | 21-000050-70 | 2020-10-01 |
| 08886483500761 | Thermodilution Catheter and Accessories | TD2755NDFX-BSI | 21-000050-92 | 2020-10-01 |
| 08886483501232 | Thermodilution Catheter and Accessories | TD1755ND-ARG(497520) | 21-000116-08 | 2020-10-01 |
| 08886483501249 | Thermodilution Catheter and Accessories | TD1755NSD-ARG(497531) | 21-000116-09 | 2020-10-01 |
| 08886483501256 | Thermodilution Catheter and Accessories | TD1704ND-ARG(497521) | 21-000117-07 | 2020-10-01 |
| 08886483501263 | Thermodilution Catheter and Accessories | TD1704NX-ARG(497526) | 21-000117-08 | 2020-10-01 |
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