FDA UDI
In Commercial Distribution
🇺🇸 United States
Exadoral®
DI: 04046955861163
·
Model: 4608660-02
·
B. BRAUN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- Exadoral®
- Primary DI
- 04046955861163
- Version / Model
- 4608660-02
- Catalog Number
- 4608660-02
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2025-09-08
- Public Version
- 2
- Public Version Date
- 2026-01-13
- Public Version Status
- Update
- Public Device Record Key
- 5b4a5280-879a-4c01-95c5-05bb35143e7c
Device Description
EXADORAL 5 ML 2-PART PURPLE PLU. STR. US
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
- 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 |
|---|---|---|---|---|
| KYX | DISPENSER, LIQUID MEDICATION | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35754 | Oral liquid dose dispenser cabinet | An electrically-powered device designed to distribute oral liquid medication/vitamins in a healthcare facility in the amount needed for a single dose for an individual patient. It typically consists of a small cabinet with an electronic pump that contains unit-dose packaged liquid drugs (e.g., glass ampules, sealed plastic containers) and/or containers with multiple doses that dispense an exact amount of liquid at a time. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04046955861170 | GS1 | Carton | 20 | In Commercial Distribution | |
| Primary | 04046955861163 | GS1 | ||||
| Unit of Use | 04046955861156 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify