PATIENT CIRCUITS

GUDID 00847946020637

KIT, PADDED CASE, TAN, ADULT AND INFANT CIRCUITS

BIO-DETEK INCORPORATED

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• Primary Device ID: 00847946020637
• NIH Device Record Key: a2f9b8cb-ab3d-4e3f-8df4-c2e2e57f7d29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PATIENT CIRCUITS
• Version Model Number: 499-0001-01
• Company DUNS: 144116225
• Company Name: BIO-DETEK INCORPORATED
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946020637 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111473

FDA Product Code

• CBK: VENTILATOR, CONTINUOUS, FACILITY USE

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: 2015-10-27

On-Brand Devices [PATIENT CIRCUITS]

• 00847946024420: MASK, QUADRALITE, MEDIUM ADULT, ANAESTHETIC WITH YELLOW CUSHION AND HOOK RING, 22F (10/CASE)
• 00847946024413: MASK, QUADRALITE, INFANT, ANAESTHETIC WITH GREY CUSHION AND HOOK RING, 15M (10/CASE)
• 00847946024406: MASK, QUADRALITE, LARGE ADULT, ANAESTHETIC WITH GREEN CUSHION AND HOOK RING, 22F (10/CASE)
• 00847946024390: KIT, BLACK, PEDIATRIC/ADULT AND INFANT CIRCUITS,MRI
• 00847946024178: KIT, PEDIATRIC/ADULT & INFANT/{EDIATRIC, SINGLE-LIMB, WYE VENTILATOR CIRCUITS 6 FT
• 00847946023232: KIT, CHILD, MASK # 4 / HARNESS, SINGLE
• 00847946023225: KIT, LARGE ADULT MASK #6 / HARNESS, SINGLE
• 00847946023218: KIT, ADULT MASK #5 / HARNESS, SINGLE /INCLUDES
• 00847946023201: CIRCUIT, MRI, VENT, SINGLE LIMB, INFANT
• 00847946023195: CIRCUIT, MRI, VENT, SINGLE LIMB, PED/ADULT
• 00847946023188: CIRCUIT, VENT, SINGLE LIMB, WYE, INFANT
• 00847946023171: CIRCUIT, VENT, SINGLE LIMB, WYE, ADULT/PEDI
• 00847946023164: MASK, CPAP, #6 LARGE ADULT
• 00847946023157: MASK, CPAP, #5 REGULAR ADULT
• 00847946023140: MASK, CPAP, #4, CHILD
• 00847946023133: MASK, CPAP, #3, SM CHILD
• 00847946023126: MASK, CPAP, #2, INFANT
• 00847946023119: MASK, CPAP, #1, SM INFANT
• 00847946023102: HARNESS, MASK, UNIVERSAL
• 00847946020934: ACCESSORY KIT, PATIENT CIRCUITS, EGL2
• 00847946020927: KIT, MRI CIRCUITS, EGL2
• 00847946020903: 499-0004-01
• 00847946020897: 499-0007-01
• 00847946020637: KIT, PADDED CASE, TAN, ADULT AND INFANT CIRCUITS
• 20847946023182: MASK, CPAP, #2, INFANT
• 20847946023137: MASK, CPAP, #3, SM CHILD
• 10847946023215: KIT, ADULT MASK #5 / HARNESS, SINGLE /INCLUDES
• 00847946028381: CIRCUIT, VENT, SINGLE LIMB, WYE, ADULT/PEDI, U.S. (SINGLE)