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

• 00616784304113 - Dmecare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 16"x16". Weight Capacity: 300 LB.
• 00616784304212 - DMECare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 18"x 16". Weight Capacity: 300 LB
• 00616784304311 - DMECare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 20" x 16". Weight Capacity: 300 LB
• 00616784304410 - DMECare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 22" x 18" Weight Capacity: 300 LB
• 00616784304519 - DMECare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 24" x 18". Weight Capacity: 300 LB
• 00840117339507 - Half Bed Rail Bumper, 1 Pair: 2025-07-04
• 00616784040028 - Ridgewood Collection Home Care Bed Full Electric: 2025-06-24 Catalog Number: 10400 KIT: 1 SET OF BOARDS (BOX 2 OF 2)
• 00616784040127 - Ridgewood Collection Home Care Bed, Semi-Electric: 2025-06-24 Catalog Number: 10401 Kit: 1 SET OF BOARDS (BOX 2 OF 2)