FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Overflow Protection / Virus Filter
DI: 07612367064682
·
Model: 101035264
·
Medela AG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Disposable Overflow Protection / Virus Filter
- Primary DI
- 07612367064682
- Version / Model
- 101035264
- Company Name
- Medela AG
- Labeler DUNS
- 488293218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2019-04-30
- Public Version
- 1
- Public Version Date
- 2019-05-08
- Public Version Status
- New
- Public Device Record Key
- 8c8998a7-e403-47dc-8f46-a80e8024a8d8
Device Description
Disposable Overflow Protection / Virus Filter, conical connection
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37798 | Suction system filter, microbial | A screening device intended to be installed within a suction system and which has a membrane pore size small enough to retain bacterial pathogens, thus preventing the environment from becoming infected and decreasing the risk of cross-infection to subsequent patients. It is typically directly connected to the suction system collection bottle/canister, or as a common filter serving more than one bottle/canister through a switching mechanism, or in a tubing line between the suction bottle/canister and the suction pump, or at the suction pump exhaust where driving gases are discarded. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07612367064699 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 07612367064682 | GS1 | ||||
| Unit of Use | 07612367064705 | GS1 |
Customer Contacts
- Phone
- +1-877-735-1626
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130123 | 000 |