FDA UDI
In Commercial Distribution
🇺🇸 United States
One-Step™
DI: 00884450032978
·
Model: 00884450032978
·
Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- One-Step™
- Primary DI
- 00884450032978
- Version / Model
- 00884450032978
- Catalog Number
- OSC-5F-7S/B
- Company Name
- Merit Medical Systems, Inc.
- Labeler DUNS
- 184763290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-16
- Public Version
- 3
- Public Version Date
- 2019-03-22
- Public Version Status
- Update
- Public Device Record Key
- 608e51d8-4c59-49cd-8419-66e37fb3289f
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GBX | CATHETER, IRRIGATION | General, Plastic Surgery | 878.4200 | 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 |
|---|---|---|---|---|---|---|
| Package | 10884450032975 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00884450032978 | GS1 | ||||
| Package | 20884450032972 | GS1 | 22 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Catheter Tip Configuration-Straight | ||
| Device Size Text, specify | Catheter Length (cm)-7 cm | ||
| Device Size Text, specify | Catheter French Size (F)-5F |