ROMA Cordless handheld sealer for blood bag tubing

GUDID 08033928530498

ROMA Cordless handheld sealer for blood bag tubing

DELCON SRL

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• Primary Device ID: 08033928530498
• NIH Device Record Key: fd209210-a049-4d13-97e0-98f4ce9cc101
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMA Cordless handheld sealer for blood bag tubing
• Version Model Number: HWONE.01
• Company DUNS: 440621212
• Company Name: DELCON SRL
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033928530498 [Primary]

FDA Product Code

• KSD: Device, Heat-Sealing

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: 2023-08-02
• Device Publish Date: 2023-07-25

Devices Manufactured by DELCON SRL

• 08033928530498 - ROMA Cordless handheld sealer for blood bag tubing: 2023-08-02ROMA Cordless handheld sealer for blood bag tubing
• 08033928530498 - ROMA Cordless handheld sealer for blood bag tubing: 2023-08-02 ROMA Cordless handheld sealer for blood bag tubing
• 08033928530795 - ROMA Charger: 2023-08-02 ROMA Charger
• 08033928530818 - HemoWeld-Gun: 2023-08-02 HemoWeld-Gun Portable sealer for blood bag tubes
• 08033928530016 - HemoMix 3: 2022-12-15 HemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag wi
• 08033928530023 - HemoMix 3: 2022-12-15 HemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag wi
• 08033928530115 - HemoWeld-T: 2022-12-15 Bench tube sealer for medical PVC tubes
• 08033928530122 - HemoWeld-Gun: 2022-12-15 HemoWeld-Gun Portable sealer for blood bag tubes - Holder Kit
• 08033928530139 - HemoWeld-Gun: 2022-12-15 Portable sealer for blood bag tubes - Case Kit