4244/M/711BRSA059/0001

GUDID 40080196149781

62.002.0099.4244/M/711BRSA

GVS Technology (Suzhou) Co., Ltd.

Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use

• Primary Device ID: 40080196149781
• NIH Device Record Key: 5a797f0e-8f9a-4c74-b65f-125fa2d43f1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4244/M/711BRSA059/0001
• Version Model Number: DYNJAAHMEHEPA
• Company DUNS: 420798347
• Company Name: GVS Technology (Suzhou) Co., Ltd.
• 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: 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: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10080196149780 [Primary]
GS1	40080196149781 [Package]; Contains: 10080196149780; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033008

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-22
• Device Publish Date: 2016-09-23

Devices Manufactured by GVS Technology (Suzhou) Co., Ltd.

• 40080196149781 - 4244/M/711BRSA059/0001: 2020-09-2262.002.0099.4244/M/711BRSA
• 40080196149781 - 4244/M/711BRSA059/0001: 2020-09-22 62.002.0099.4244/M/711BRSA
• 25060511621780 - ECO Maxi filter: 2019-03-04
• 35019315082973 - ECO Range - Phase 1: 2018-07-06
• 35019315082997 - ECO Range - Mini Series: 2018-07-06
• 35019315083031 - 9080/750BRSA074/0001: 2018-07-06
• 35019315083208 - ECO Maxi Pleat - Pleated HEPA Filter: 2018-07-06
• 35019315083215 - ECO Range - Maxi Series: 2018-07-06
• 35019315083291 - ECO Range - Maxi Series: 2018-07-06