Davol® Infant Cath Kit
Davol® Infant Cath Kit - 0035630
Device Description
A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Catheter Gauge: 5 French
- Length: 1.67 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FFH
Device Name: Collector, Urine, Pediatric, For Indwelling Catheter
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 876.5250
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 10801741045841
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00801741045844
Package Quantity: 50
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CA
Device Id: 00801741045844
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A