ME+1000 _ DS _ G1/2 S

GUDID 08592346821026

MediEvac+ is variable control medical suction equipment powered from a vacuum source used for vacuum regulation. MediEvac+ is intended for suction of body liquids from any part of a patient's body during surgical operations, resuscitation, chest and gastritic drainage, etc. The product is not intended to be powered from: • a venturi vacuum source • a pressure gas source. The product is not intended for: • field use • direct use during thoracic drainage

GCE, s.r.o.

Vacuum suction regulator/regulation set, general-purpose

• Primary Device ID: 08592346821026
• NIH Device Record Key: 4ab1347e-8ca0-4561-a212-14d47a704c01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ME+1000 _ DS _ G1/2 S
• Version Model Number: 0735104US
• Company DUNS: 819753190
• Company Name: GCE, s.r.o.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08592346821026 [Primary]

FDA Product Code

• KDP: Regulator, Vacuum

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: 2022-07-25
• Device Publish Date: 2022-07-15

Devices Manufactured by GCE, s.r.o.

• 08592346978812 - MediVital E: 2025-08-18 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
• 08592346893382 - Varimed: 2025-03-25 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
• 08592346893399 - Varimed+: 2025-03-25 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
• 08592346893405 - Varimed: 2025-03-25 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
• 08592346893412 - Varimed+: 2025-03-25 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
• 08592346893429 - Varimed: 2025-03-25 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
• 08592346893436 - Varimed: 2025-03-25 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
• 08592346918276 - Varimed: 2025-03-25 The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.