Pip 942

GUDID 10732671209426

Glucose Control Solutions L1(Low) and L2 (High) - 2 Vials 2.5dL each

AMITY HOLDINGS, LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: 10732671209426
• NIH Device Record Key: 21a69fca-4d73-44c1-bcf3-3abf2566a97f
• Commercial Distribution Discontinuation: 2026-05-13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pip
• Version Model Number: 942
• Catalog Number: 942
• Company DUNS: 016069284
• Company Name: AMITY HOLDINGS, LLC
• 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: 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

Device Dimensions

• Total Volume: 5 Deciliter
• Total Volume: 5 Deciliter
• Total Volume: 5 Deciliter
• Total Volume: 5 Deciliter
• Total Volume: 5 Deciliter
• Total Volume: 5 Deciliter
• Total Volume: 5 Deciliter
• Total Volume: 5 Deciliter
• Total Volume: 5 Deciliter
• Total Volume: 5 Deciliter
• Total Volume: 5 Deciliter
• Total Volume: 5 Deciliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10732671209426 [Primary]
GS1	20732671309420 [Package]; Package: Corrugate Carton [340 Units]; Discontinued: 2026-05-13; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113208

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2021-06-29
• Device Publish Date: 2021-06-21

On-Brand Devices [Pip]

• 10732671109351: Lancing Device with Ejector
• 20732671209348: 33ga Twist Lancets
• 30732671309335: Insulin Pen Needle 31ga X 6.0mm
• 30732671309328: Insulin Pen Needle 31ga X 5.0mm
• 30732671309311: Insulin Pen Needle 32ga X 4.0mm
• 00732671009036: Safety Lancet
• 00732671009029: Safety Lancet
• 00732671009012: Safety Lancet
• 60732671609030: PIP Trial Pack: 30ea 903; 10ea 901; 10ea 902
• 60732671609023: PIP Trial Pack: 30ea 902; 10ea 901; 10ea 903
• 60732671609016: PIP Lancet Trial Pack: 30ea 901; 10ea 902; 10ea 903
• 10732671209426: Glucose Control Solutions L1(Low) and L2 (High) - 2 Vials 2.5dL each
• 00732671109422: Control Solution - L2 (High)
• 00732671009425: Control Solution - L1 (low)
• 00732671009418: Blood Glucose Test Strips
• 00732671009401: Blood Glucose Test Meter
• 10732671102338: 28G Lancet