Aero-Med CA44175

GUDID 50885380194274

Kit Blood Culture Adult 21G for Rangely Hospital District Only

AERO-MED, LLC

Phlebotomy kit

• Primary Device ID: 50885380194274
• NIH Device Record Key: 02e3561e-7df2-4fc5-ba9a-47a250e5bacf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aero-Med
• Version Model Number: CA44175
• Catalog Number: CA44175
• Company DUNS: 194550042
• Company Name: AERO-MED, LLC
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885380194276 [Primary]
GS1	50885380194274 [Package]; Contains: 10885380194276; Package: CASE [25 Units]; In Commercial Distribution

FDA Product Code

• OIB: Blood and urine collection kit (excludes HIV testing)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-05-29
• Device Publish Date: 2023-01-30

On-Brand Devices [Aero-Med]

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• 50885380198739: Kit Blood Collection Venous Draw for UAB Only
• 50885380194281: Kit Blood Culture Pediatric 23G for Rangely Hospital District Only
• 50885380194274: Kit Blood Culture Adult 21G for Rangely Hospital District Only
• 50885380178267: Blood Collection Kit, Line Draw, Augusta University Medical Center Only
• 50885380177000: Blood Culture Kit, Ped Peripheral, University of Kansas Only
• 50885380176997: Blood Culture Kit, Adult Central Line, University of Kansas Only
• 50885380176980: Adult Blood Culture Kit, University of Kansas Hospital Only
• 50885380175907: Urine Collection Toxicology Kit, Hennepin Healthcare Only
• 50885380174184: Urine Foley Collection Kit, Baptist Health System Only
• 50885380170308: Blood Culture Collection Kit, Baptist Brookwood Only
• 50885380169838: Blood Culture Collection Kit, Pediatric, Tallahassee Memorial Hospital Only
• 50885380169821: Blood Culture Collection Kit, Tallahassee Memorial Hospital Only
• 50885380141469: Offsite - Venous Blood Collection Kit
• 50885380140189: BLOOD CULTURE KIT -Pediatric
• 50885380140172: BLOOD CULTURE KIT - Adult
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• 50810010890509: ThinPrep Collection Tools; Combo
• 50810010890493: ThinPrep Collection Tools; Broom
• 50810010890479: SurePath Collection Tools; Combo
• 50810010890462: SurePath Collection Tools; Broom
• 00810010892836: Convenience Packaging Kit
• 50810010894804: Fine Needle Aspiration Kit