FDA UDI
In Commercial Distribution
🇺🇸 United States
kitazato IUI Catheter
DI: 04580303269237
·
Model: 131181 Type5-v1
·
KITAZATO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- kitazato IUI Catheter
- Primary DI
- 04580303269237
- Version / Model
- 131181 Type5-v1
- Catalog Number
- 131181
- Company Name
- KITAZATO CORPORATION
- Labeler DUNS
- 711091157
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-25
- Public Version
- 8
- Public Version Date
- 2023-08-07
- Public Version Status
- Update
- Public Device Record Key
- c2b30496-e93a-4b61-bf80-a79e1a7b083d
Device Description
Catheter with Outer Stiffener with Stainless Steel Core, 18cm, model number Type5-v1
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| MQF | CATHETER, ASSISTED REPRODUCTION | Obstetrics/Gynecology | 884.6110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45846 | Assisted reproduction transfer catheter/set | A device or collection of devices that includes a flexible polymer tube intended to be used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)]. In addition to the ‘live transfer’ catheter it may also include a trial transfer catheter intended to assess/ensure that embryo placement will be successful; it typically also includes devices intended to assist catheter introduction (e.g., outer guide sheath, stylet). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14580303269234 | GS1 | 50 | Not in Commercial Distribution | 2023-01-18 | |
| Primary | 04580303269237 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162667 | 000 |