Product Code: FOC
FDA class 2
21 CFR 876.5250
Bag, Urine Collection, Newborn
Gastroenterology, Urology
The Newborn Urine Collection Bag is a small adhesive bag designed to be attached to a newborn's perineum to collect a urine specimen for diagnostic laboratory testing without requiring catheterization. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FOC, regulated under 21 CFR 876.5250 in the Gastroenterology and Urology specialty.
510(k)s
4
FEI Numbers
10
Registration Numbers
10
Unique Applicants
4
Years Active
18
Basic Information
- Product Code
- FOC
- Device Class
- FDA class 2
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950176 | PREMIE U-BAG URINE SPECIMEN COLLECTOR | Feb 07, 1995 | Substantially Equivalent | Hollister, Inc. |
| K943752 | RIMECO MIDSTREAM URINE COLLECTOR | Nov 01, 1994 | Substantially Equivalent | Rimeco Products, Inc. |
| K911329 | BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE | May 28, 1991 | Substantially Equivalent | C.R. Bard, Inc. |
| K771368 | PORTABLE INFANT VENTILATOR | Aug 04, 1977 | Substantially Equivalent | Cavitron Corp. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.