Coulmed DI-5403

GUDID 30810087350001

Sterile Mini C-Arm Cover fitted for OEC Mini 6600/6800 C-Arms: 48" x 84"

Coulmed Products Group LLC

Medical equipment drape, single-use

• Primary Device ID: 30810087350001
• NIH Device Record Key: 7cca442b-6987-4a3c-a7ee-49c55fdbe548
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coulmed
• Version Model Number: DI-5403
• Catalog Number: DI-5403
• Company DUNS: 047115479
• Company Name: Coulmed Products Group LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	10810087350007 [Primary]
GS1	30810087350001 [Package]; Contains: 10810087350007; Package: Case [25 Units]; In Commercial Distribution

FDA Product Code

• PUI: Drape, surgical, exempt

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: 2024-07-25
• 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
• 30810087350353: Premium Chemotherapy Gown, Perforated Back, Thumb Holes, Blue Polyethylene
• 30810087350346: Standard Sterile Surgical Gown, with Towel, XX-Large, AAMI 4
• 30810087350339: Standard Sterile Surgical Gown, with Towel, X-Large, AAMI 4
• 30810087350322: Standard Sterile Surgical Gown, with Towel, Large, AAMI 4
• 30810087350315: Standard Sterile Surgical Gown, Poly Reinforced, XX-Large, AAMI 3
• 30810087350308: Standard Sterile Surgical Gown, Poly Reinforced, X-Large, AAMI 3
• 30810087350292: Standard Sterile Surgical Gown, Poly Reinforced, Large, AAMI 3
• 30810087350285: Standard Sterile Surgical Gown, XX-Large, AAMI 3
• 30810087350278: Standard Sterile Surgical Gown, X-Large, AAMI 3
• 30810087350261: Standard Sterile Surgical Gown, Large, AAMI 3
• 30810087350254: Round SMS Bouffant Cap 27"
• 30810087350230: Bouffant Caps, 24", Blue Polypropylene, Latex free
• 30810087350223: Pleated SMS Bouffant Caps, 24", White Polypropylene, Latex free
• 30810087350216: Pleated Bouffant Caps, 21", Blue Polypropylene, Latex free, Double Elastic Band
• 30810087350209: Pleated SMS Bouffant Caps, 21", White Polypropylene, Latex free, Double Elastic Band
• 30810087350179: Heavy-Duty SMS Shoe Covers with Skid-Resistant Tread
• 10810087351073: Mayo Stand Cover, 21" X 18-1/2" X 5/8"
• 30810087350162: Covex Sterile Microscope Drape for Leica: 54" x 150" (137cm x 381cm)
• 30810087350155: Covex Sterile Microscope Drape for Leica: 54" x 120" (137cm x 305cm)
• 30810087350148: Covex Sterile Microscope Drape for Leica: 46" x 120"
• 30810087350131: Covex Sterile Microscope Drape for Zeiss MD: 46" x 120" (117cm x 305cm)
• 30810087350124: Covex Sterile Microscope Drape for Zeiss MD: 54" x 150"
• 30810087350117: Covex Sterile Microscope Drape for Zeiss MD: 46" x 105"
• 30810087350100: Covex Sterile X-Ray Cassette Cover: 24" x 24"
• 30810087350094: Covex Sterile C-Arm Cover Kit fitted for OEC Elite, 9900, 9800, 9600, and Brivo C-Arm's. Include
• 30810087350087: Covex Sterile C-Arm Drape with Tape/Bands: 41" x 74"
• 30810087350070: Covex Sterile C-Arm Drape with Elastic Bands: 41" x 74"
• 30810087350063: Covex Sterile C-Arm Cover: 41" x 74"
• 30810087350056: Covex Sterile Dome Cover: 27" Polyethylene Bag with Elastic Band
• 30810087350049: Covex Sterile C-Arm Cover: Half Bag with Latex-Free Band, 36"W x 80"L
• 30810087350032: Covex Sterile C-Arm Cover fitted for Fluoroscan Mini C-Arm, With Elastic Opening, 54" x 78"
• 30810087350025: Foot Switch Cover, Disposable, 17" X 15"
• 30810087350018: Covex Sterile Mini C-Arm Cover fitted for OrthoScan C-Arm, Keyboard, and Monitor Handles