ulrich medical disposables

GUDID 04052536203697

Spike for MRI (CM) - holder l for ulricheasyINJECT MRI injectors

Ulrich GmbH & Co. KG

Contrast medium injection system administration set

• Primary Device ID: 04052536203697
• NIH Device Record Key: 7f9fb564-a3ba-4428-816a-4aa9bef616e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ulrich medical disposables
• Version Model Number: XD 10755
• Company DUNS: 315494757
• Company Name: Ulrich GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536203673 [Primary]
GS1	04052536203680 [Package]; Package: [8 Units]; In Commercial Distribution
GS1	04052536203697 [Package]; Contains: 04052536203673; Package: [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233737

FDA Product Code

• IZQ: Injector, Contrast Medium, Automatic

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: 2024-06-06
• Device Publish Date: 2024-05-29

On-Brand Devices [ulrich medical disposables]

• 04052536203864: Patient tubing without RFID, 320 cm for ulricheasyINJECT CT/MRI injectors
• 04052536203840: Patient tubing without RFID, 250 cm for ulricheasyINJECT CT/MRI injectors
• 04052536203710: Spike for MRI (CM) - holder s for ulricheasyINJECT MRI injectors
• 04052536203697: Spike for MRI (CM) - holder l for ulricheasyINJECT MRI injectors
• 04052536203659: Spike for CT (CM/NaCl), MRI (NaCl) for ulricheasyINJECT CT/MRI injectors
• 04052536175239: Easy-Click-Cassette 2M - flex for ulricheasyINJECT CT/MRI injectors
• 04052536175147: Easy-Click-Cassette 3 - flex for ulricheasyINJECT CT/MRI injectors
• 04052536166480: Patient tubing, 320 cm for ulricheasyINJECT CT/MRT injectors
• 04052536166466: Patient tubing, 250 cm for ulricheasyINJECT CT/MRT injectors