TC 560 Contact Liquid

GUDID 07332834000264

TC 560 Contact Liquid (20 ml)

Perimed AB

Transcutaneous blood gas monitoring system

• Primary Device ID: 07332834000264
• NIH Device Record Key: 796227bc-964e-458f-bd3a-809877d1b3f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TC 560 Contact Liquid
• Version Model Number: TC 560
• Company DUNS: 354765570
• Company Name: Perimed AB
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332834000264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990960

FDA Product Code

• KLK: Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-13

Devices Manufactured by Perimed AB

• 07332834000790 - PF 6840-1 TC Remote Panel 1 Channel: 2023-02-09 PF 6840-1 TC Remote Panel 1 Channel
• 07332834000806 - PF 6840-2 TC Remote Panel 2 Channels: 2023-02-09 PF 6840-2 TC Remote Panel 2 Channels
• 07332834000820 - PF 6840-4 TC Remote Panel 4 Channels: 2023-02-09 PF 6840-4 TC Remote Panel 4 Channels
• 07332834000066 - PeriFlux 6000: 2021-10-28 PeriFlux 6000
• 07332834000608 - PH 07-5 Small Tape-Fixated Probe Holder: 2021-06-02 PH 07-5 Small Tape-Fixated Probe Holder (5 pcs)
• 07332834000387 - MT B500-0L120 Straight Microtip: 2020-04-23 MT B500-0L120 Straight Microtip
• 07332834000394 - MT B500-0L240 Straight Microtip: 2020-04-23 MT B500-0L240 Straight Microtip
• 07332834000288 - TC 550 Fixation Ring for tcpO2/CO2 (50 pcs) and TC 560 Contact Liquid: 2019-12-13 Convenience kit including: TC 550 Fixation Ring for tcpO2/CO2 (50 pcs) TC 560 Contact Liquid (20 ml)