Opt-Shield Air Supine OSA90X39SUP

GUDID 00868680000310

Non sterile single use OR table drape with forced-air warming and safe patient positioning capabilities.

BCG MEDICAL, LLC

Circulating-air whole-body heating/cooling system pad, single-use, non-sterile

• Primary Device ID: 00868680000310
• NIH Device Record Key: 29b36ce3-8d07-4008-a7fb-c3f7770c420f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opt-Shield Air Supine
• Version Model Number: OSA90X39SUP
• Catalog Number: OSA90X39SUP
• Company DUNS: 968666839
• Company Name: BCG MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com
• Phone: 858-939-6272
• Email: Rafael.Cruz@sharp..com

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868680000310 [Primary]
GS1	10868680000317 [Package]; Package: box [5 Units]; In Commercial Distribution

FDA Product Code

• DWJ: System, Thermal Regulating

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: 2019-04-17
• Device Publish Date: 2018-06-29

Devices Manufactured by BCG MEDICAL, LLC

• 10868680000300 - Opt-Shield: 2019-04-18 Non sterile single use OR table drape with warm air circulating and safe patient positioning capabilities.
• 00868680000310 - Opt-Shield Air Supine: 2019-04-17Non sterile single use OR table drape with forced-air warming and safe patient positioning capabilities.
• 00868680000310 - Opt-Shield Air Supine: 2019-04-17 Non sterile single use OR table drape with forced-air warming and safe patient positioning capabilities.