FDA UDI
In Commercial Distribution
🇺🇸 United States
Monoject
DI: 10884521082946
·
Model: 8881540133
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Monoject
- Primary DI
- 10884521082946
- Version / Model
- 8881540133
- Catalog Number
- 8881540133
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-30
- Public Version
- 2
- Public Version Date
- 2019-02-15
- Public Version Status
- Update
- Public Device Record Key
- d01a90e4-1ffb-499d-aa1d-3df9b8ee5f98
Device Description
Vial Access Cannula,Smart Tip
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 |
|---|---|---|---|---|
| GEA | CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45316 | Medicine preparation needle/cannula, sterile | A sterile slender metallic or plastic tube with a blunt distal end intended to be attached to a syringe in order to aspirate pharmaceutical fluids from vials or ampules during the preparation of some medications performed by healthcare professionals (e.g., pharmacists, physicians, nurses). This device is not intended for skin injections or tissue manipulation. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40884521082947 | GS1 | PACK_OR_INNER_PACK | 100 | In Commercial Distribution | |
| Primary | 10884521082946 | GS1 | ||||
| Package | 30884521082940 | GS1 | CASE | 800 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 3 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry;AVOID DIRECT SUNLIGHT