FDA UDI
In Commercial Distribution
🇺🇸 United States
Monoject
DI: 10884521140950
·
Model: 412SG
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Monoject
- Primary DI
- 10884521140950
- Version / Model
- 412SG
- Catalog Number
- 412SG
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-27
- Public Version
- 3
- Public Version Date
- 2023-06-09
- Public Version Status
- Update
- Public Device Record Key
- f21cb7bb-2262-4e87-bfdf-9473070b79f6
- Distribution End Date
- 2025-12-31
Device Description
Enteral Syringe with Tip Cap
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
- No
- 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 |
|---|---|---|---|---|
| KYW | CONTAINER, LIQUID MEDICATION, GRADUATED | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64514 | Oral/enteral medicine medicated administration kit, single-use | A collection of devices with an included pharmaceutical intended to be used for the oral and/or enteral administration of an accurate dosage of the included medication. In addition to the pharmaceutical, it will include a dose measuring and/or dispensing device(s) such as a calibrated syringe, medicine cup, or spoon, and may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884521140957 | GS1 | PACK_OR_INNER_PACK | 48 | In Commercial Distribution | 2025-12-31 |
| Primary | 10884521140950 | GS1 | ||||
| Package | 30884521140954 | GS1 | CASE | 192 | In Commercial Distribution | 2025-12-31 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 12 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry;AVOID DIRECT SUNLIGHT