FDA UDI
In Commercial Distribution
🇺🇸 United States
Kumar Catheter®
DI: B361CC0190
·
Model: CC019
·
NASHVILLE SURGICAL INSTRUMENTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Kumar Catheter®
- Primary DI
- B361CC0190
- Version / Model
- CC019
- Catalog Number
- CC-019
- Company Name
- NASHVILLE SURGICAL INSTRUMENTS, LLC
- Labeler DUNS
- 030096122
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-15
- Public Version
- 4
- Public Version Date
- 2024-05-03
- Public Version Status
- Update
- Public Device Record Key
- b243bd66-2330-4f16-ad1a-0f037f481d94
Device Description
The Kumar Catheter®, used in conjunction with Kumar Cholangiography® Clamp, is meant to provide a means of laparoscopic cholangiography. It comprises a translucent tubing ( 76 cm. length and 16 ga. ) that carries a 19 ga., 1.25 cm long needle at the end. The Kumar Catheter® is used to puncture the Hartmann's pouch of the gallbladder for biliary access and / or aspiration. Product is latex free.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| GBZ | Catheter, Cholangiography | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62668 | Laparoscopic cholangiography injection catheter/needle | A flexible, single-lumen tube with a distal needle intended to puncture the neck of the gallbladder (Hartmann’s pouch) during laparoscopic cholangiography to allow injection of contrast media. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B361CC0190 | HIBCC | ||||
| Package | B361CC0191 | HIBCC | Box | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 615-382-4996
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973621 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 45 – 85 Degrees Fahrenheit