Custom Medical Specialties

GUDID 00815849023277

Large Bore Infiltration Set - Sterile

CUSTOM ASSEMBLIES, INC.

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• Primary Device ID: 00815849023277
• NIH Device Record Key: 9472369c-6ad3-480b-baae-45d7a6a0c54e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Custom Medical Specialties
• Version Model Number: CMS-1213
• Company DUNS: 948904735
• Company Name: CUSTOM ASSEMBLIES, INC.
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815849023253 [Primary]
GS1	00815849023277 [Package]; Contains: 00815849023253; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993463

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-09-25

On-Brand Devices [Custom Medical Specialties]

• 00815849023055: 72" Drainage Hose - Sterile
• 00815849023277: Large Bore Infiltration Set - Sterile
• 00815849023291: 20" LS Extension Set - Sterile
• 00815849023352: Film Reinforced XXL Gown - Sterile