FDA UDI
In Commercial Distribution
🇺🇸 United States
CADD
DI: 15019517154993
·
Model: 21-2112-0402-51
·
Smiths Medical ASD, Inc.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CADD
- Primary DI
- 15019517154993
- Version / Model
- 21-2112-0402-51
- Company Name
- Smiths Medical ASD, Inc.
- Labeler DUNS
- 082005361
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-05
- Public Version
- 3
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- cc0515ab-e92e-4c58-a29e-b17711b7022b
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PYR | Neuraxial Administration Set - Intrathecal delivery | General Hospital | 880.5440 | 2 |
| MRZ | ACCESSORIES, PUMP, INFUSION | General Hospital | 880.5725 | 2 |
| MEA | Pump, infusion, pca | General Hospital | 880.5725 | 2 |
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13215 | Bedside infusion pump, single-channel | An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15019517154993 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170982 | 000 |