FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Filter paper for autoclavable bacteria filter
DI: 07612367011365
·
Model: 077.1014
·
Medela AG
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- Filter paper for autoclavable bacteria filter
- Primary DI
- 07612367011365
- Version / Model
- 077.1014
- Company Name
- Medela AG
- Labeler DUNS
- 488293218
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2021-09-01
- Public Version
- 3
- Public Version Date
- 2026-02-02
- Public Version Status
- Update
- Public Device Record Key
- 46b2af98-e2c9-4408-a4b9-a709f0a82495
- Distribution End Date
- 2026-01-31
Device Description
Filter paper for autoclavable bacteria filter
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
- 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 |
|---|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | General, Plastic Surgery | 878.4780 | 2 |
| HDB | Extractor, Vacuum, Fetal | Obstetrics/Gynecology | 884.4340 | 2 |
| MUU | System, Suction, Lipoplasty | General, Plastic Surgery | 878.5040 | 2 |
| QPB | System, Suction, Lipoplasty For Removal | General, Plastic Surgery | 878.5040 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 07612367080569 | GS1 | ||||
| Primary | 07612367011365 | GS1 |
Customer Contacts
- Phone
- +1-877-735-1626
- [email protected]