FDA UDI
In Commercial Distribution
🇺🇸 United States
Irrigation Set
DI: 10887787006695
·
Model: 653665
·
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
- 10887787006695
- Version / Model
- 653665
- Catalog Number
- 0653665
- 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
- 2018-06-28
- Public Version
- 1
- Public Version Date
- 2018-07-30
- Public Version Status
- New
- Public Device Record Key
- cae3f19e-af36-4815-93c0-de41d59e733f
Device Description
LATEX-FREE CATHETER IRRIGATION SET, Convertible Pin, 70 Inch (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 |
|---|---|---|---|---|
| 34930 | Single-administration urethral drainage/irrigation catheter | A sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder to provide one episode of irrigation and/or drainage of the bladder. It is typically inserted by a healthcare professional. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20887787006692 | GS1 | case | 20 | In Commercial Distribution | |
| Primary | 10887787006695 | GS1 | ||||
| Secondary | M3356536650 | HIBCC |
Customer Contacts
- Phone
- +1(877)946-7747
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Approximate priming volume : 12 Milliliter | ||
| Length | 70 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature. Avoid Excessive Heat. Protect from Freezing