FDA UDI
In Commercial Distribution
🇺🇸 United States
Suction jar, 1 lt
DI: 07612367007016
·
Model: 080.0023
·
Medela AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Suction jar, 1 lt
- Primary DI
- 07612367007016
- Version / Model
- 080.0023
- Company Name
- Medela AG
- Labeler DUNS
- 488293218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-24
- Public Version
- 6
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 94dbac84-bd3a-4c81-9bfb-f7b6ffd7b0c1
Device Description
Suction jar, polysulfone, 1l OKM, K7503762
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 |
|---|---|---|---|---|
| 44943 | Surgical suction system collection container, reusable | A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07612367045292 | GS1 | 16 | In Commercial Distribution | ||
| Primary | 07612367007016 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150134 | 000 |