FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE
DI: 10884389114094
·
Model: DYNJE5910
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MEDLINE
- Primary DI
- 10884389114094
- Version / Model
- DYNJE5910
- Catalog Number
- DYNJE5910
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-26
- Public Version
- 1
- Public Version Date
- 2024-12-04
- Public Version Status
- New
- Public Device Record Key
- f7080549-5247-4807-ae48-e2de95a9a0e7
Device Description
COVER,PROBE,W/GEL AND BANDS, 6X24
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITX | Transducer, ultrasonic, diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44714 | Intraoperative ultrasound imaging transducer cover | A sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used intraoperatively, e.g., on internal organs, during an ultrasound examination. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40884389114095 | GS1 | CS | 20 | In Commercial Distribution | |
| Primary | 10884389114094 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight. Keep dry.