Guerbet Ext/Inj line Straight CT/MR 240004

GUDID 13661657031058

150 cm Straight Extension/Injection Line for CT & MRI

CAIR LGL

Intravenous administration tubing extension set

• Primary Device ID: 13661657031058
• NIH Device Record Key: ab063b61-f9a9-403a-afbf-eda14dfd82fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guerbet Ext/Inj line Straight CT/MR
• Version Model Number: PN-MDX3515M
• Catalog Number: 240004
• Company DUNS: 380834713
• Company Name: CAIR LGL
• Device Count: 1
• DM Exempt: false
• 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: false
• 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	13661657031058 [Primary]
GS1	23661657031055 [Package]; Package: Carton box [25 Units]; In Commercial Distribution
GS1	33661657031052 [Package]; Contains: 53661657031056; Package: Carton box [400 Units]; In Commercial Distribution
GS1	53661657031056 [Package]; Contains: 23661657031055; Package: Carton box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171118

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2023-05-02
• Device Publish Date: 2023-04-24

Devices Manufactured by CAIR LGL

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• 13661657051759 - Vesco Medical Pediatric Nasogastric Feeding Tubes: 2023-05-04 Vesco Medical CH/FR 4 L 60 cm (24 in.) Pediatric Nasogastric Feeding Tubes Enfit Single Port - PU
• 23661657051770 - Vesco Medical Pediatric Nasogastric Feeding Tubes: 2023-05-04 Vesco Medical CH/FR 6 L 60 cm (24 in.) Pediatric Nasogastric Feeding Tubes Enfit Single Port - PU
• 13661657052220 - Vesco Medical Nasogastric Feeding Tubes: 2023-05-04 Vesco Medical CH/FR 4 L 40 cm (16 in.) Nasogastric Feeding Tubes ENFit Single Port - PVC
• 23661657052234 - Vesco Medical Nasogastric Feeding Tubes: 2023-05-04 Vesco Medical CH/FR 5 L 40 cm (16 in.) Nasogastric Feeding Tubes ENFit Single Port - PVC
• 23661657052241 - Vesco Medical Nasogastric Feeding Tubes: 2023-05-04 Vesco Medical CH/FR 6 L 40 cm (16 in.) Nasogastric Feeding Tubes ENFit Single Port - PVC
• 23661657052258 - Vesco Medical Nasogastric Feeding Tubes: 2023-05-04 Vesco Medical CH/FR 8 L 40 cm (16 in.) Nasogastric Feeding Tubes ENFit Single Port - PVC
• 13661657052268 - Vesco Medical Nasogastric Feeding Tubes: 2023-05-04 Vesco Medical CH/FR 10 L 40 cm (16 in.) Nasogastric Feeding Tubes ENFit Single Port - PVC