Volumat™ Line M46441395

GUDID 04250273750294

IV administration set for infusion pumps

Fresenius Kabi AG

Electric infusion pump administration set, single-use

• Primary Device ID: 04250273750294
• NIH Device Record Key: 6f689b95-c0b1-47ad-a20a-140fc8e2b4fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Volumat™ Line
• Version Model Number: VL SP10-PE
• Catalog Number: M46441395
• Company DUNS: 315654579
• Company Name: Fresenius Kabi AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at controlled room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250273750294 [Primary]
GS1	04250273750300 [Package]; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221121

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: 2024-03-29
• Device Publish Date: 2024-03-21

On-Brand Devices [Volumat™ Line]

• 04250273733891: For use with the Volumat primary lines.
• 04250273733860: For use with Agilia VP MC pumps / Volumat MC Agilia pump or gravity only.
• 04250273731972: VL PR44-12
• 04250273731958: VL PR40-11
• 04250273731910: VL ST10-X0
• 04250273731897: VL SL00-X0
• 04250273731873: VL ON72-X1
• 04250273731859: VL ST02-X0
• 4250273714821: VL SP 62-1
• 04250273714517: VL ST 10-0
• 4250273714500: VL PA 92-1
• 4250273714487: VL SL 00-0
• 4250273714463: VL TR 00-0
• 4250273714449: VL PR 42-41
• 4250273714401: VL ON 72-1
• 4250273714388: VL PN 02-1
• 4250273714364: VL PR 42-12
• 4250273714340: VL PR 72-11
• 4250273714326: VL PA 92-2
• 4250273714302: VL PR 42-21
• 4250273714289: VL ST 02-0
• 4250273714265: VL PR 42-11
• 04250273714234: VL PR 22-1
• 4250273714197: VL SP 22-0
• 04250273750294: IV administration set for infusion pumps
• 04250273750287: IV administration set for infusion pumps
• 04250273750218: IV administration set for infusion pumps
• 04250273750164: IV administration set for infusion pumps