FDA UDI
In Commercial Distribution
🇺🇸 United States
CAREFLOW(TM) 1 LUMEN 5FR X 200MM
DI: 00886333616640
·
Model: 681664
·
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CAREFLOW(TM) 1 LUMEN 5FR X 200MM
- Primary DI
- 00886333616640
- Version / Model
- 681664
- Catalog Number
- 681664
- Company Name
- ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
- Labeler DUNS
- 595138793
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2024-03-20
- Public Version Status
- Update
- Public Device Record Key
- 0cda1581-f695-46fe-b06f-efcd372b7ca6
Device Description
Kits Contents : Catheter with Floswitch(TM) 5FR OD 1.75mmx200mm; J guidewire OD 0.9mmx700mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Floswitch(TM) Overneedle Introducer 15G OD 1.7mmx70mm, Dilator 8FR OD 2.69mm ID 0.96mm.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| FOZ | Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50886333616645 | GS1 | Tyvek Tray | 100 | In Commercial Distribution | |
| Primary | 00886333616640 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Catheter with Floswitch(TM) 5FR OD 1.75mmx200mm |