FDA UDI
In Commercial Distribution
🇺🇸 United States
JACKSON-PRATT
DI: 10885380061554
·
Model: SU1301305D
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- JACKSON-PRATT
- Primary DI
- 10885380061554
- Version / Model
- SU1301305D
- Catalog Number
- SU1301305D
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-10
- Public Version
- 3
- Public Version Date
- 2018-07-23
- Public Version Status
- Update
- Public Device Record Key
- 3be366ac-71f6-41d7-af38-59fbb440b807
Device Description
100CC SILICONE BULB RESERVOIR
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 11301 | Closed-wound/centesis drainage receptacle | A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885380061554 | GS1 | ||||
| Package | 20885380061551 | GS1 | BOX | 10 | In Commercial Distribution | |
| Package | 50885380061552 | GS1 | Case | 3 | In Commercial Distribution |