Exchange Select

GUDID 00614299396432

Exchange Select One Step Ovulation Predictor

SPD SWISS PRECISION DIAGNOSTICS GMBH

Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit

• Primary Device ID: 00614299396432
• NIH Device Record Key: b1f73251-1090-4b3d-ac70-94a5469c3fd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exchange Select
• Version Model Number: One Step Ovulation Predictor
• Company DUNS: 483609579
• Company Name: SPD SWISS PRECISION DIAGNOSTICS GMBH
• Device Count: 7
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: true

Customer Support Contacts

• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614299396432 [Primary]
GS1	00633472000140 [Unit of Use]
GS1	10614299396439 [Package]; Package: Shipping case [6 Units]; In Commercial Distribution

FDA Product Code

• CEP: Radioimmunoassay, Luteinizing Hormone

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: 2019-03-11
• Device Publish Date: 2019-03-01

On-Brand Devices [Exchange Select ]

• 00614299396432: Exchange Select One Step Ovulation Predictor
• 10614299437385: Exchange Select DPS +/-Blue Cap