Klein Tumescent Infiltration Pump KTIP

GUDID 00816989021123

Klein Tumescent Infiltration Pump

HK SURGICAL INC.

Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel

• Primary Device ID: 00816989021123
• NIH Device Record Key: 902dc711-477c-44bc-9e36-c7d2dfbeaf60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klein Tumescent Infiltration Pump
• Version Model Number: KTIP
• Catalog Number: KTIP
• Company DUNS: 106885259
• Company Name: HK SURGICAL 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• 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	00816989021123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123822

FDA Product Code

• FRN: Pump, Infusion

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: 2022-08-19
• Device Publish Date: 2022-08-11

Devices Manufactured by HK SURGICAL INC.

• 00816989021130 - HK Mercedes Cannula 3mm X 15cm Luer Lock: 2023-12-29 HK-2010-MER315LL (HK-2010 Mercedes Cannula 3mm X 15cm Luer Lock)
• 00816989021147 - HK Mercedes Cannula 2mm X 15cm Luer Lock: 2023-12-29 HK-2010-MER215LL (HK-2010 Mercedes Cannula 2mm X 15cm Luer Lock)
• 00816989021154 - HK Mercedes Cannula 3mm X 25cm Luer Lock: 2023-12-29 HK-2010-MER325LL (HK-2010 Mercedes Cannula 3mm X 25cm Luer Lock)
• 00816989021161 - HK Mercedes Cannula 3mm X 30cm (12") Luer Lock: 2023-12-29 HK-2010-MER330LL (HK-2010 Mercedes Cannula 3mm X 30cm (12") Luer Lock)
• 00816989021178 - HK Mercedes Cannula 4mm X 25cm Luer Lock: 2023-12-29 HK-2010-MER425LL (HK-2010 Mercedes Cannula 4mm X 25cm Luer Lock)
• 00816989021185 - HK Mercedes Cannula 4mm X 30cm (12") Luer Lock: 2023-12-29 HK-2010-MER430LL (HK-2010 Mercedes Cannula 4mm X 30cm (12") Luer Lock)
• 00816989021192 - HK HK-2015-MER+215LL (HK-2015 Mercedes Plus Cannula 2mm x 15cm Luer Lock): 2023-12-29 HK-2015-MER+215LL (HK-2015 HK-2015-MER+215LL (HK-2015 Mercedes Plus Cannula 2mm x 15cm Luer Lock)
• 00816989021208 - HK Mercedes Plus Cannula 3mm X 25cm Luer Lock: 2023-12-29 HK-2015-MER+325LL (HK-2015 Mercedes Plus Cannula 3mm X 25cm Luer Lock)