FDA UDI
In Commercial Distribution
🇺🇸 United States
Bact-Trap Mini Port
DI: 30734000671564
·
Model: 7055
·
Pharma Systems Ps AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bact-Trap Mini Port
- Primary DI
- 30734000671564
- Version / Model
- 7055
- Catalog Number
- 7055
- Company Name
- Pharma Systems Ps AB
- Labeler DUNS
- 356335752
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-24
- Public Version
- 1
- Public Version Date
- 2023-11-01
- Public Version Status
- New
- Public Device Record Key
- f5889866-2a31-4fab-8c9d-b6a6c4b5c21f
Device Description
Bacterial/Viral 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
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAH | Filter, bacterial, breathing-circuit | Anesthesiology | 868.5260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60837 | Microbial medical gas filter, single-use | A screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30734000671564 | GS1 |
Customer Contacts
- Phone
- +4618349500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202459 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6.8 | Centimeter |