FDA UDI
In Commercial Distribution
🇺🇸 United States
BD PhaSeal™ Optima Infusion Clamp M25-O
DI: 00382905150852
·
Model: 515085
·
BECTON DICKINSON PEN LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BD PhaSeal™ Optima Infusion Clamp M25-O
- Primary DI
- 00382905150852
- Version / Model
- 515085
- Catalog Number
- 515085
- Company Name
- BECTON DICKINSON PEN LIMITED
- Labeler DUNS
- 988402590
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-30
- Public Version
- 1
- Public Version Date
- 2020-07-08
- Public Version Status
- New
- Public Device Record Key
- f1cd279d-8f34-45f7-b38f-31aaca97f4b5
Device Description
M25-O Infusion Clamp
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KMK | DEVICE, INTRAVASCULAR CATHETER SECUREMENT | General Hospital | 880.5210 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63390 | Intravenous line closed infusion system clamp | A non-sterile device in the form of a closable housing intended to enclose and secure the connection (e.g., Luer connection) between mating components of a closed infusion system [e.g., closed system drug transfer device (CSTD)] attached to a patient’s IV line to help prevent inadvertent separation of the closed infusion system components. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30382905150853 | GS1 | Shelfpack | 25 | In Commercial Distribution | |
| Primary | 00382905150852 | GS1 | ||||
| Package | 50382905150857 | GS1 | Case | 4 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature