FDA UDI
In Commercial Distribution
🇺🇸 United States
Invia Liberty Y-Connector with quick connector
DI: 07612367041201
·
Model: 087.0023
·
Medela AG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Invia Liberty Y-Connector with quick connector
- Primary DI
- 07612367041201
- Version / Model
- 087.0023
- Company Name
- Medela AG
- Labeler DUNS
- 488293218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-03
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 89506d1e-5f5d-4f72-b6e7-7701be38d267
Device Description
Tubing for negative pressure wound therapy powered suction pump
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 07612367049580 | GS1 | 16 | In Commercial Distribution | ||
| Package | 07612367049573 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 07612367041201 | GS1 |
Customer Contacts
- Phone
- +1-877-735-1626
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142626 | 000 |