DTS-3000

GUDID 08809802644236

Device 1ea, SILICONE BLADDER CUFF(DTC-SA1843 1ea, DTC-SA2443 1ea, DTC-SA3043 1ea, DTC-SA3443 1ea, DTC-CD1855 1ea), Hose set (Red 1ea, Blue 1ea, Gray 2ea), IOP Sensor

DAESUNG MAREF CO.,LTD.

Surgical pneumatic tourniquet system

• Primary Device ID: 08809802644236
• NIH Device Record Key: 6611eb9f-ada0-4389-a0e0-563f5bd7c1fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DTS-3000
• Version Model Number: DTSW410-SS-2
• Company DUNS: 688817949
• Company Name: DAESUNG MAREF 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809802644236 [Primary]

FDA Product Code

• KCY: Tourniquet, Pneumatic

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: 2023-08-07
• Device Publish Date: 2023-07-28

On-Brand Devices [DTS-3000]

• 18809315676608: AC SINGLE CUFF (DTC-SA15) 1ea
• 18809315676592: AC SINGLE CUFF (DTC-SA07) 1ea
• 18809315676585: AC SINGLE CUFF (DTC-SA06) 1ea
• 18809315676578: AC SINGLE CUFF (DTC-SA05) 1ea
• 18809315676561: AC SINGLE CUFF (DTC-SA02) 1ea
• 18809315676554: AC SINGLE CUFF (DTC-SA01) 1ea
• 18809315676530: IOP Sensor 1ea
• 18809315676523: GRAY MAIN HOSE 1ea
• 18809315676516: BLUE MAIN HOSE 1ea
• 18809315676509: RED MAIN HOSE 1ea
• 18809315676493: Cone Double Cuff (DTC-CD27) 1ea
• 18809315676486: Cone Double Cuff (DTC-CD26) 1ea
• 18809315676479: Cone Double Cuff (DTC-CD25) 1ea
• 18809315676431: Double Cuff(DTC-D07) 1ea
• 18809315676370: Double Cuff (DTC-D06) 1ea
• 18809315676356: Double Cuff (DTC-D05) 1ea
• 18809315676332: Double Cuff (DTC-D04) 1ea
• 18809315676264: Cone Single Cuff (DTC-C27) 1ea
• 18809315676257: Cone Single Cuff (DTC-C26) 1ea
• 18809315676240: Cone Single Cuff (DTC-C25 1ea)
• 18809315676233: Gray hose 1ea
• 18809315676226: Blue hose 1ea
• 18809315676219: Red hose 1ea
• 08809315676199: Hose set (Red 1ea, Blue 1ea, Gray 2ea)
• 08809315676182: Device 1ea, AC SINGLE CUFF(DTC-SA02 1ea, DTC-SA05 1ea, DTC-SA06 1ea, DTC-SA07 1ea, DTC-SA15 1ea)
• 08809315676175: Device 1ea, Single Cuff (DTC-S05 1ea, DTC-S06 1ea), Cone Single Cuff(DTC-C26 1ea), Double Cuff (
• 18809315676165: AC SINGLE CUFF (DTC-SA02 1ea, DTC-SA05 1ea, DTC-SA06 1ea, DTC-SA07 1ea, DTC-SA15 1ea)
• 18809315676158: Single Cuff (DTC-S05 1ea, DTC-S06 1ea), Cone Single Cuff (DTC-C26 1ea) Double Cuff (DTC-D04 1ea,
• 18809315676141: Single Cuff(DTC-S08) 1ea
• 18809315676134: Single Cuff(DTC-S07) 1ea
• 18809315676127: Single Cuff(DTC-S06) 1ea
• 18809315676110: Single Cuff (DTC-S05) 1ea
• 18809315676103: Single Cuff (DTC-S04) 1ea
• 18809315676097: Single Cuff (DTC-S02) 1ea
• 08809315676076: Device 1ea
• 08809802643956: Device 1ea, AC Single Cuff(DTC-SA02 1ea, DTC-SA06 1ea), Cone Single Cuff(DTC-C26 1ea), Double Cu
• 08809802643284: Device 1ea, Hose set (Red 1ea, Blue 1ea, Gray 2ea), IOP Sensor [One set box]
• 08809315676304: Device 1ea, Single Cuff(DTC-S02 1ea, DTC-S04 1ea), Cone Single Cuff(DTC-C25 1ea, DTC-C26 1ea, DT
• 08809802644236: Device 1ea, SILICONE BLADDER CUFF(DTC-SA1843 1ea, DTC-SA2443 1ea, DTC-SA3043 1ea, DTC-SA3443 1ea