FDA UDI
In Commercial Distribution
🇺🇸 United States
PremierPro
DI: 00818566016898
·
Model: 7243
·
PRESTIGE AMERITECH, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- PremierPro
- Primary DI
- 00818566016898
- Version / Model
- 7243
- Catalog Number
- 7243
- Company Name
- PRESTIGE AMERITECH, LTD.
- Labeler DUNS
- 199692794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-29
- Public Version
- 2
- Public Version Date
- 2026-03-23
- Public Version Status
- Update
- Public Device Record Key
- ffd41153-2992-4cdc-b69c-a0bafe13bd98
Device Description
Standard IV Start Kit: Tegaderm™ 1614, IV Change Label, ChloraPrep® Frepp® 1.5ml, 2"x2" 4-ply Gauze, Transpore™ Tape .75"x18", Orange Tourniquet .75"x18"
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
- 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 |
|---|---|---|---|---|
| LRS | I.V. Start Kit | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33963 | Peripheral intravenous catheterization support kit | A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10818566016895 | GS1 | case | 100 | In Commercial Distribution | |
| Primary | 00818566016898 | GS1 |
Customer Contacts
- Phone
- 1-855-531-7699
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius