FDA UDI
In Commercial Distribution
🇺🇸 United States
Flex-Neck®
DI: 00884450170342
·
Model: 00884450170342
·
Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Flex-Neck®
- Primary DI
- 00884450170342
- Version / Model
- 00884450170342
- Catalog Number
- CF-5249/A
- Company Name
- Merit Medical Systems, Inc.
- Labeler DUNS
- 184763290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-31
- Public Version
- 4
- Public Version Date
- 2021-10-11
- Public Version Status
- Update
- Public Device Record Key
- 713ab8c5-c7ba-402e-aeaa-ca7634365787
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| FJS | CATHETER, PERITONEAL, LONG-TERM INDWELLING | Gastroenterology, Urology | 876.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47086 | Peritoneal dialysis catheter, chronic | A tube used to infuse a solution (dialysate) into the peritoneal cavity, allowing metabolic wastes/fluid to diffuse from the blood to the dialysate using the peritoneum as the dialysing membrane. It is usually surgically or endoscopically implanted, percutaneously, for long-term use; it may be provided with Dacron cuffs to promote tissue ingrowth for the prevention of fluid leaks and bacterial penetration. It may be used in manual continuous ambulatory peritoneal dialysis (CAPD), automated continuous cyclic peritoneal dialysis, intraperitoneal chemotherapy, or to eliminate fluid overload in congestive heart failure. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10884450170349 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00884450170342 | GS1 | ||||
| Package | 20884450170346 | GS1 | 30 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | I.D. (mm)-3.5 mm | ||
| Device Size Text, specify | Number of Cuffs-1 Cuff | ||
| Device Size Text, specify | Overall Length Straight (cm)-62.0 cm | ||
| Device Size Text, specify | Catheter Tip configuration-Coiled |