FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 15019517065879
·
Model: ED32115-CM
·
SMITHS MEDICAL ASD, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 15019517065879
- Version / Model
- ED32115-CM
- Company Name
- SMITHS MEDICAL ASD, INC.
- Labeler DUNS
- 137835299
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-19
- Public Version
- 6
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 80b32243-9d8b-4d74-b82b-2e4092412465
- Distribution End Date
- 2018-04-30
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
- 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 |
|---|---|---|---|---|
| MEG | SYRINGE, ANTISTICK | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59230 | Hypodermic needle, single-use | A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 55019517065877 | GS1 | CASE | 8 | Not in Commercial Distribution | 2018-04-30 |
| Package | 35019517065873 | GS1 | BOX | 50 | Not in Commercial Distribution | 2018-04-30 |
| Primary | 15019517065879 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061194 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 21G x 1 1/2" (0.8mm x 38mm) |