FDA UDI
In Commercial Distribution
🇺🇸 United States
RENASYS® Y-Connector
DI: 05000223493592
·
Model: 66020971
·
SMITH & NEPHEW MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- RENASYS® Y-Connector
- Primary DI
- 05000223493592
- Version / Model
- 66020971
- Catalog Number
- 66020971
- Company Name
- SMITH & NEPHEW MEDICAL LIMITED
- Labeler DUNS
- 216344051
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-24
- Public Version
- 5
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- e9c0fc49-9e47-4ae6-b80d-a7d2c4713272
Device Description
RENASYS Y-Connector US Non-sterile
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47409 | Negative-pressure wound therapy tubing set | A collection of sterile, flexible, plastic tubing and associated items (e.g., connectors, line clamp, negative pressure applicator pad, canister) intended to be used as part of a vacuum-assisted wound closure system; commonly known as negative pressure wound therapy (NPWT). It is designed to create an airtight connection between the open-cell foam dressing and drape at the wound site and the vacuum pump. The tubing allows negative pressure to be delivered to the wound site and provides a conduit to channel excess interstitial fluid, wound exudate, and infectious materials from the wound to the collection canister. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05000223493592 | GS1 | ||||
| Package | 05000223493608 | GS1 | case | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181204 | 000 |