FDA UDI
In Commercial Distribution
🇺🇸 United States
ASEPT
DI: 04046964317330
·
Model: 622284
·
B BRAUN INTERVENTIONAL SYSTEMS, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ASEPT
- Primary DI
- 04046964317330
- Version / Model
- 622284
- Catalog Number
- 622284
- Company Name
- B BRAUN INTERVENTIONAL SYSTEMS, INC
- Labeler DUNS
- 784259751
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-26
- Public Version
- 10
- Public Version Date
- 2024-04-16
- Public Version Status
- Update
- Public Device Record Key
- 030a9ca2-7f31-4bdb-b2e1-6f4bf0d30bbd
Device Description
ASEPT PERITONEAL DRAINAGE SYSTEM
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
- No
- 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 |
|---|---|---|---|---|
| PNG | Peritoneal, drainage catheter for refractory ascites, long-term indwelling | Gastroenterology, Urology | 876.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61520 | Peritoneal drainage catheter | A sterile flexible tube designed for percutaneous insertion into the peritoneal space typically to drain ascites and abdominal abscesses. It may include disposable devices dedicated to catheter introduction, however it does not include any fluid collection bags/containers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964317330 | GS1 |
Customer Contacts
- Phone
- +1(877)836-2228
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temp