FDA UDI
In Commercial Distribution
🇺🇸 United States
Closed Wound Suction
DI: 00801741049385
·
Model: 0043650
·
C. R. Bard, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Closed Wound Suction
- Primary DI
- 00801741049385
- Version / Model
- 0043650
- Catalog Number
- 0043650
- Company Name
- C. R. Bard, Inc.
- Labeler DUNS
- 016898496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-22
- Public Version
- 2
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- c43a3bed-4795-4dc4-b54d-2ce8c19d15cc
Device Description
CWS 400 Closed Wound Suction Kit, 400cc Evauactor, 3-spring, Y-Connecting Tube
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCY | APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED | General, Plastic Surgery | 878.4680 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35824 | Closed-wound drainage kit | A collection of devices designed to remove fluids or purulent material from a closed-wound in a controlled manner. It includes a container (the receptacle or reservoir), drains/catheters, connectors, a grasping device and possibly a trocar for placing the drains/catheters into the site. The reservoir will usually be provided with graduated markers along its side to facilitate the approximate measurement of the collected fluids. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741049382 | GS1 | BX | 5 | In Commercial Distribution | |
| Primary | 00801741049385 | GS1 | ||||
| Package | 20801741049389 | GS1 | CA | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)526-4455
- [email protected]