FDA UDI
In Commercial Distribution
🇺🇸 United States
Additive
DI: 10887787001874
·
Model: 485801
·
HOSPIRA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
Basic Information
- Brand Name
- Additive
- Primary DI
- 10887787001874
- Version / Model
- 485801
- Catalog Number
- 0485801
- Company Name
- HOSPIRA, INC.
- Labeler DUNS
- 141588017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 4
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- 3710fa68-36fa-4ad4-923e-eb33daa027fe
Device Description
LATEX-FREE ADDITIVE HINGE CAP LifeCare Flexible Container
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KPE | CONTAINER, I.V. | General Hospital | 880.5025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58977 | Basic intravenous administration set, noninvasive | A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20887787001871 | GS1 | case | 10 | In Commercial Distribution | |
| Primary | 10887787001874 | GS1 | ||||
| Secondary | M3354858011 | HIBCC | ||||
| Unit of Use | 00887787001877 | GS1 |
Customer Contacts
- Phone
- +1(877)946-7747
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Controlled Room Temperature. Avoid Excessive Heat. Protect from Freezing