SpeediCath Flex Set 28941

GUDID 05708932755856

Coloplast A/S

Single-administration urethral catheterization kit, single-use

• Primary Device ID: 05708932755856
• NIH Device Record Key: 08cf0e6c-2278-4b44-ac71-fa3e5b8b17da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeediCath Flex Set
• Version Model Number: 28941
• Catalog Number: 28941
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Gauge: 10 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932747684 [Primary]
GS1	05708932755856 [Package]; Contains: 05708932747684; Package: Shipper Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222059

FDA Product Code

• FCM: Tray, catheterization, sterile urethral, with or without catheter (kit)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-09
• Device Publish Date: 2022-12-01

On-Brand Devices [SpeediCath Flex Set]

• 05701780221559: SpeediCath Flex Set CH16
• 05701780221658: SpeediCath Flex Set CH14
• 05701780221641: SpeediCath Flex Set CH12
• 05701780221627: SpeediCath Flex Set CH10
• 05708932753081: 28946
• 05708932755894: 28944
• 05708932755870: 28942
• 05708932755856: 28941