N/A AT15-DS

GUDID 46923980104426

Theta Circuit, 150cm

GaleMed Xiamen Co., Ltd.

Ventilator breathing circuit, single-use

• Primary Device ID: 46923980104426
• NIH Device Record Key: d29b1e4e-2534-46e3-8e96-1daabe5c4274
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: AB0260
• Catalog Number: AT15-DS
• Company DUNS: 527333326
• Company Name: GaleMed Xiamen Co., Ltd.
• 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	06923980104428 [Primary]
GS1	46923980104426 [Package]; Contains: 06923980104428; Package: Carton [20 Units]; In Commercial Distribution

FDA Product Code

• BZO: Set, Tubing And Support, Ventilator (W Harness)
• CAI: Circuit, Breathing (W Connector, Adaptor, Y Piece)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-30
• Device Publish Date: 2024-10-22

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• 46923980115187: Anesthesia Circuit, Adult, 1.8m
• 46923980115170: Anesthesia Circuit, Adult, 1.2m
• 46923980115163: Coaxial Circuit, Adult, 1.8m
• 46923980115156: Anesthesia Circuit, Adult, 1.5m
• 46923980110502: CPAP Face Mask Set w/Hose, S
• 46923980110496: CPAP Face Mask Set w/Hose, M
• 46923980104747: CPAP Face Mask Set w/Hose, L
• 46923980107281: Connector, 15F, 10/7.6mm, K Resin
• 46923980103672: Mouth Piece, 13M
• 46923980107748: Connector, 15M, 5F, PP
• 46923980106420: (10)Flex Trach Adaptor 15cm, 22M/15F-22F
• 46923980106413: (10)Flex Trach Adapt 15cm,22M/15F-15M
• 46923980106406: Flex Trach Adaptor 15cm, 22M/15F-22F
• 46923980105485: Neb.Easy AM-1 Mask, Child w/Tube
• 46923980105461: Neb.Easy AM-1 Mask, Adult w/Tube
• 46923980105430: Neb.Easy Nebulizer w/Mouth Piece, Tube
• 46923980103689: Neb.Easy AM-1 Mask, Infant w/Tube