FDA UDI
In Commercial Distribution
🇺🇸 United States
Excelsior
DI: 10363807103358
·
Model: E0103-35
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Excelsior
- Primary DI
- 10363807103358
- Version / Model
- E0103-35
- Catalog Number
- E0103-35
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 8f45ca52-dc80-4c10-9374-e3403a18198a
Device Description
SwabFlush®
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
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NGT | Saline, vascular access flush | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61142 | Vascular access device flush/disinfection tool | A manual device intended to be used to flush wash the lumen of an in situ vascular access device (e.g., catheter, needleless intravenous line) and to disinfect the device’s Luer access valve. It consists of a prefilled syringe containing a saline solution, and a disinfection cap or scrubber containing a foam material saturated with disinfectant [e.g., isopropyl alcohol (IPA)]. It may be supplied as a one-piece or modular device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20363807103355 | GS1 | case | 8 | In Commercial Distribution | |
| Primary | 10363807103358 | GS1 | ||||
| Unit of Use | 00363807103351 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130975 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3 mL fill in 10 mL flush syringe with integrated SwabCap® | ||
| Total Volume | 3 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius