Cleansing Enema Set

GUDID 00616784471136

Cleansing Enema Set: 1500mL Enema Bag, 60" Inlet Tubing, Tubing Clamp, Protection Clamp, Protection Cap, Castile Soap Concentrate, 45x42cm Moisture Proof Drape

DYNAREX CORPORATION

Manual enema device, single-use

• Primary Device ID: 00616784471136
• NIH Device Record Key: 451a0934-12d5-45ff-8fc9-f7b75b7b29cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cleansing Enema Set
• Version Model Number: 4711
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784471129 [Primary]
GS1	00616784471136 [Package]; Contains: 00616784471129; Package: Case [50 Units]; In Commercial Distribution

FDA Product Code

• FCE: Enema Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-29
• Device Publish Date: 2021-06-21

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