FDA UDI
In Commercial Distribution
🇺🇸 United States
Aspiracath
DI: 00827002172708
·
Model: G17270
·
COOK INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aspiracath
- Primary DI
- 00827002172708
- Version / Model
- G17270
- Catalog Number
- J-ASP-092500
- Company Name
- COOK INCORPORATED
- Labeler DUNS
- 042823948
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-04
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 567166e0-6a8f-4ee7-b3e4-da34e0e78bf0
Device Description
Aspiracath
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HFC | ASPIRATOR, ENDOCERVICAL | Obstetrics/Gynecology | 884.1050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47070 | Cervical aspiration catheter | A semi-rigid, sterile, tube designed to aspirate cervical mucous, typically for the evaluation of infertility. It is used to obtain cervical mucous samples for post-coital determination of spermatic hostility; it may also be used to remove a viscous mucous barrier prior to intrauterine insemination, embryo transfer, or other transcervical procedures. The tube usually contains a rigid inner tube with a plunger that is positioned near the distal end; once in situ, the plunger is slowly withdrawn, creating a suction that draws mucous into the tube. The mucous is typically expelled onto a microscope slide for examination. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00827002172708 | GS1 |
Customer Contacts
- Phone
- +1(812)330-5494
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dark, dry, cool place.