FDA UDI
In Commercial Distribution
🇺🇸 United States
ASEPT®
DI: 04046964317491
·
Model: 622288
·
B BRAUN INTERVENTIONAL SYSTEMS, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- ASEPT®
- Primary DI
- 04046964317491
- Version / Model
- 622288
- Catalog Number
- 622288
- Company Name
- B BRAUN INTERVENTIONAL SYSTEMS, INC
- Labeler DUNS
- 784259751
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-08-09
- Public Version
- 6
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 8df81af0-1699-4f5d-b2c2-eb9d6d975cb7
Device Description
ASEPT REPLACEMENT VALVE
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 |
|---|---|---|---|---|
| DWM | APPARATUS, SUCTION, PATIENT CARE | Cardiovascular | 870.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35375 | Stopcock | A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964317491 | GS1 | ||||
| Unit of Use | 04046964317477 | GS1 |
Customer Contacts
- Phone
- +1(877)836-2228
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY
- Type
- Special Storage Condition, Specify
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temp