FDA UDI
In Commercial Distribution
🇺🇸 United States
Passio Adapter Kit
DI: 00860099001353
·
Model: PAS-06
·
Bearpac Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Passio Adapter Kit
- Primary DI
- 00860099001353
- Version / Model
- PAS-06
- Company Name
- Bearpac Medical, LLC
- Labeler DUNS
- 081178202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-11
- Public Version
- 1
- Public Version Date
- 2023-08-21
- Public Version Status
- New
- Public Device Record Key
- 464d6f6e-1093-467c-bb50-333cbea97624
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 |
|---|---|---|---|---|
| DWM | Apparatus, Suction, Patient Care | Cardiovascular | 870.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47797 | Pleural/peritoneal drainage catheterization kit | A collection of sterile devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions, ascites, and/or air. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller). It also includes additional non-dedicated catheterization support devices (e.g., disposable scissors, gloves, dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860099001353 | GS1 | ||||
| Package | 10860099001350 | GS1 | CASE | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201404 | 000 |