FDA UDI
In Commercial Distribution
🇺🇸 United States
Plum
DI: 10887787008903
·
Model: 1968328
·
HOSPIRA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Plum
- Primary DI
- 10887787008903
- Version / Model
- 1968328
- Catalog Number
- 1968328
- Company Name
- HOSPIRA, INC.
- Labeler DUNS
- 141588017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- 6acdf42e-c6b8-43f5-bbdf-54183f3da151
Device Description
LIFESHIELD LATEX-FREE MICRO SOLUSET, CONVERTIBLE PIERCING PIN, PLUMSET, FILTER, CLAVE PORT, OPTION LOK, NON-DEHP
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 20887787008900 | GS1 | case | 24 | In Commercial Distribution | |
| Primary | 10887787008903 | GS1 | ||||
| Secondary | M33519683281 | HIBCC |
Customer Contacts
- Phone
- +1(877)946-7747
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Approximate priming volume : 14 Milliliter | ||
| Length | 118 | Inch | |
| Device Size Text, specify | Drop Size : 60 Drops / Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature. Avoid Excessive Heat. Protect from Freezing