FDA UDI
In Commercial Distribution
🇺🇸 United States
TEVADAPTOR® Connecting Set with ULTRASITE® Injection Site
DI: 27298119121151
·
Model: MG412115
·
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- TEVADAPTOR® Connecting Set with ULTRASITE® Injection Site
- Primary DI
- 27298119121151
- Version / Model
- MG412115
- Catalog Number
- MG412115
- Company Name
- TEVA PHARMACEUTICAL INDUSTRIES LIMITED
- Labeler DUNS
- 600029649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 5
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- 6221a96d-2277-4940-9781-d6951213f248
Device Description
TEVADAPTOR® Connecting Set with ULTRASITE® Injection Site for use with OnGuardTM contained Medication System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58977 | Basic intravenous administration set, noninvasive | A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 27298119121151 | GS1 | ||||
| Unit of Use | 07298119121157 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141306 | 000 |