Aero-Med CA59150

GUDID 50885380203334

Kit Flow Cytometry for Sagis Dx Only

Aero-Med, Ltd.

Blood/tissue storage/culture container

• Primary Device ID: 50885380203334
• NIH Device Record Key: 50fe6487-50d5-4dc6-964e-9ffbe7763198
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aero-Med
• Version Model Number: CA59150
• Catalog Number: CA59150
• Company DUNS: 194550042
• Company Name: Aero-Med, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885380203336 [Primary]
GS1	50885380203334 [Package]; Contains: 10885380203336; Package: CASE [25 Units]; In Commercial Distribution

FDA Product Code

• KDD: Kit, surgical instrument, disposable

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: 2024-08-09
• Device Publish Date: 2024-08-01

On-Brand Devices [Aero-Med]

• 50885380169852: Blood Culture Kit, Direct Draw, BD Media, Cleveland Clinic Only
• 50810010892039: Specimen Collection
• 50810010890936: Blood Collection Pack
• 50810010890929: Blood Collection Pack
• 50885380107434: MD Pathology Kit
• 50885380104273: Urine Transfer Device; Kit
• 10810011100043: Urine Collection Kit
• 50810011100034: 200C Convenience Packaging
• 50810011100010: Chest Tube Kit Non-Sterile
• 50810010892084: Specimen Container; Convenience Packaging
• 50810010892077: Fine Needle Aspiration Kit
• 10810010892055: Hair Collection Kit DOA Testing
• 10810010892048: 72 Hour Stool Collection
• 10810010892017: Adhesive Skin Sample Collection Kit
• 10810010891256: CRO Supplies Kit
• 50810010891018: Urine Transfer Device; Individually Wrapped
• 10810010890983: Serum Separator Card
• 10810010890976: Serum Separator Card
• 10810010890969: Blood Collection Kit Aceva
• 10810010890952: Blood Collection Kit Bulk
• 10810010890945: Blood Collection Kit Bulk
• 50810010890912: Blood Collection
• 10810010890907: Blood Spot Collection Kit
• 50810010890899: VPA Urine Kit
• 50810010890868: Urine Collection Kit
• 50810010890851: Urine Collection Kit
• 50810010890837: ED Urine Collection Kit
• 50810010890820: Kit; L and D Urine Collection
• 50810010890578: Labeled EDTA Tubes
• 50810010890561: Fine Needle Aspiration Kit
• 50810010890554: Inherigen Kit
• 50810010890547: Prenatal Kit
• 50810010890530: Prenatal Kit
• 50810010890523: Prenatal Kit
• 10810010890440: Kit; Repackaging 455071P
• 10810010890433: Kit; Repackaging 367964
• 10810010890426: Kit; Repackaging 367964
• 10810010890419: Kit; Repackaging 367861
• 10810010890402: Kit; Repackaging 367861
• 10810010890372: Small Direct to Patient Kit
• 10810010890358: Large Blood Collection Kit
• 10810010890341: Large Blood Collection Kit
• 10810010890334: Individual Patient Pack
• 10810010890327: Individual Patient Pack
• 10810010890310: Individual Patient Pack
• 10810010890303: Small NMR Blood Collection Kit
• 10810010890297: Swab Convenience Pack
• 10810010890273: Buccal Swab Kit
• 50810010890226: Urine Foley Catheter Kit
• 50810010890219: Urine Transfer Cup and Straw Kit