Coulmed DI-1420

GUDID 30810087350469

Sterile 3/4 Drape/Sheet: 57" x 63"

Coulmed Products Group LLC

Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use

• Primary Device ID: 30810087350469
• NIH Device Record Key: a01bffeb-6cbf-4d3f-b489-cf383755fbbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coulmed
• Version Model Number: DI-1420
• Catalog Number: DI-1420
• Company DUNS: 047115479
• Company Name: Coulmed Products Group LLC
• 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	10810087350465 [Primary]
GS1	30810087350469 [Package]; Contains: 10810087350465; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101689

FDA Product Code

• KKX: Drape, Surgical

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: 2024-07-02
• Device Publish Date: 2023-01-06

On-Brand Devices [Coulmed]

• 10810087355965: Gel Pediatric Chest Roll, Flat Bottom Surface, 3"W x 10"L x 3"T
• 10810087355989: Replacement Pad for Skytron 3501B Surgical Table; Body Section Only; 2" thich, Tier II Pressure
• 10810087355972: Replacement Pads for Skytron 3501B Surgical Table; 3 Piece Set; 2" thick, Tier II Pressure Relie
• 10810087356047: Replacement Pad for MIDMARK 7100 Surgical Table, Leg/Foot Section Only, 2" thick, Standard Foam,
• 10810087356030: Replacement Pad for MIDMARK 7100 Surgical Table, Head Section Only, 2" thick, Standard Foam, Bla
• 30810087350476: Universal Sterile Mayo Stand Drape/Cover: 23" x 54"
• 30810087350469: Sterile 3/4 Drape/Sheet: 57" x 63"
• 30810087350452: Covex Heavy Duty Sterile Drape for OR Specific Two Tier Back Table: One Piece Construction, 6' L
• 30810087350445: Covex Heavy Duty Sterile Drape for OR Specific Two Tier Back Table: One Piece Construction, 5' L
• 30810087350438: Covex Heavy Duty Sterile Drape for OR Specific Two Tier Back Table: One Piece Construction, 4' L
• 30810087350421: Covex Custom Sterile Drape for Two Tier Tables with 8" Back, One Piece Construction, 72"Long
• 30810087350414: Covex Heavy Duty Sterile Drape for Two Tier Back Table: One Piece Construction, 72"Long
• 30810087350407: 60" Wide Custom Double Back Table Cover
• 30810087350391: Covex Heavy Duty Sterile Drape for Two Tier Back Table: One Piece Construction, 60"Long
• 30810087350384: Covex Heavy Duty Sterile Drape for Two Tier Back Table: One Piece Construction, 49"Long
• 30810087350377: Covex Sterile Camera Drape with Blue Elasticized Tip: 7" x 96"
• 30810087350360: Covex Sterile Probe Cover with Gel: 5" x 96" inch