FDA UDI
In Commercial Distribution
🇺🇸 United States
Irrigation Set
DI: 10887787006749
·
Model: 659901
·
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
- 10887787006749
- Version / Model
- 659901
- Catalog Number
- 0659901
- 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
- 2
- Public Version Date
- 2019-01-23
- Public Version Status
- Update
- Public Device Record Key
- f434232e-2bb2-4124-95b2-9c5aef9657bc
Device Description
LATEX-FREE LARGE BORE Y-IRRIGATION SET Nonvented Set 100 Inch (254 cm) For Flexible Irrigation Container Systems (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 |
|---|---|---|---|---|
| 58752 | Arthroscopic access cannula, single-use | A single-lumen surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20887787006746 | GS1 | case | 20 | In Commercial Distribution | |
| Primary | 10887787006749 | GS1 | ||||
| Secondary | M3356599010 | HIBCC |
Customer Contacts
- Phone
- +1(877)946-7747
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 100 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature. Avoid Excessive Heat. Protect from Freezing