FDA UDI
In Commercial Distribution
🇺🇸 United States
Irrigation Set
DI: 10887787007241
·
Model: 1523901
·
ICU MEDICAL FLEET SERVICES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Irrigation Set
- Primary DI
- 10887787007241
- Version / Model
- 1523901
- Catalog Number
- 1523901
- Company Name
- ICU MEDICAL FLEET SERVICES, LLC
- Labeler DUNS
- 830767898
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-31
- Public Version
- 3
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- 56b814f8-a063-40e1-8652-a54086f856f5
Device Description
LATEX-FREE 4-LEAD T-U-R IRRIGATION SET Nonvented Set for Transurethral Resection Procedures 85 inch (216 cm) (previously Hospira product)
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
- 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 |
|---|---|---|---|---|
| GBX | CATHETER, IRRIGATION | General, Plastic Surgery | 878.4200 | 1 |
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 | 20887787007248 | GS1 | case | 10 | In Commercial Distribution | |
| Primary | 10887787007241 | GS1 | ||||
| Secondary | M33515239010 | HIBCC |
Customer Contacts
- Phone
- +1(877)946-7747
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 85 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature. Avoid Excessive Heat. Protect from Freezing