Guerbet 50cm Ext/Inj line Straight CT/MR 240001

GUDID 13661657031409

50 cm Straight Extension/Injection Line CT & MRI

CAIR LGL

Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set

• Primary Device ID: 13661657031409
• NIH Device Record Key: 471056c8-2f58-48a6-9a0a-2eca4bb81e3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guerbet 50cm Ext/Inj line Straight CT/MR
• Version Model Number: PN-MDX3205M
• Catalog Number: 240001
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	13661657031409 [Primary]
GS1	23661657031406 [Package]; Package: Carton box [40 Units]; In Commercial Distribution
GS1	33661657031403 [Package]; Contains: 53661657031407; Package: Carton box [640 Units]; In Commercial Distribution
GS1	53661657031407 [Package]; Contains: 23661657031406; Package: Carton box [160 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

• 13661657051735 - Vesco Medical Pediatric Nasogastric Feeding Tubes: 2023-05-04 Vesco Medical CH/FR 4 L 40 cm (16 in.) Pediatric Nasogastric Feeding Tubes Enfit Single Port - PU
• 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