Urethral Intermittent Catheter Tray

GUDID 00616784492834

DYNAREX CORPORATION

Urethral catheterization support kit, urinary drainage

• Primary Device ID: 00616784492834
• NIH Device Record Key: bfa53f2c-9c1b-465b-b33f-27f4a5bcf20f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urethral Intermittent Catheter Tray
• Version Model Number: 4928
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784492827 [Unit of Use]
GS1	00616784492834 [Primary]

FDA Product Code

• OHR: Catheter Care Tray

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-11-22

Devices Manufactured by DYNAREX CORPORATION

• 00840117340398 - Resp-O2 Disposable Guedel Airway, 90 mm, Adult Medium, Yellow: 2024-12-30
• 00840117340404 - Resp-O2 Disposable Guedel Airway, 100 mm, Adult Large, Red: 2024-12-30
• 00840117340411 - Resp-O2 Disposable Guedel Airway, 110 mm, Adult X-Large, Orange: 2024-12-30
• 00840117326620 - Resp-O2 Homecare 800 cc Suction Disposable Canister Full Kit: 2024-12-23 Includes: 800 cc Canister with Float Lid, 1/3" x 6' Suction Tubing, Ridged Elbow Connector, Soft Elbow Connector, Hydrophobic Sh
• 00840117339057 - Durma+ Transparent Film Dressing, Frame Style, Sterile: 2024-12-23 Sterile-EO, Size: 2.36" x 2.75" (6 cm x 7 cm)
• 00840117339088 - Durma+ Transparent Film Dressing, Frame Style, 4" x 4.75" (10 cm x 12 cm ): 2024-12-23 Sterile-EO
• 00840117340213 - Overbed Table H Base, Silver Vein, Walnut: 2024-12-23
• 00840117340220 - Overbed Table, H Base, Silver Vein, Mahogany: 2024-12-23