Perry Sigma Monoplace

GUDID 00852678007085

HYPERBARIC SYSTEM, 40" MONOPLACE CHAMBER WITH UNDERCARRIAGE

PERRY BAROMEDICAL CORPORATION

Hyperbaric chamber, stationary

• Primary Device ID: 00852678007085
• NIH Device Record Key: 76b16a86-91cc-405b-8bf5-4cf0cc65c853
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perry Sigma Monoplace
• Version Model Number: Sigma 40 w/Undercarriage
• Company DUNS: 616251443
• Company Name: PERRY BAROMEDICAL CORPORATION
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Width: 46 Inch
• Width: 46 Inch
• Width: 46 Inch
• Width: 46 Inch
• Weight: 3050 Pound
• Height: 73.2 Inch
• Length: 105 Inch
• Width: 46 Inch
• Weight: 3050 Pound
• Height: 73.2 Inch
• Length: 105 Inch
• Width: 46 Inch
• Weight: 3050 Pound
• Height: 73.2 Inch
• Length: 105 Inch
• Width: 46 Inch
• Weight: 3050 Pound
• Height: 73.2 Inch
• Length: 105 Inch
• Width: 46 Inch
• Weight: 3050 Pound
• Height: 73.2 Inch
• Length: 105 Inch
• Width: 46 Inch
• Weight: 3050 Pound
• Height: 73.2 Inch
• Length: 105 Inch
• Width: 46 Inch
• Weight: 3050 Pound
• Height: 73.2 Inch
• Length: 105 Inch
• Width: 46 Inch
• Weight: 3050 Pound
• Height: 73.2 Inch
• Length: 105 Inch
• Width: 46 Inch
• Weight: 3050 Pound
• Height: 73.2 Inch
• Length: 105 Inch
• Width: 46 Inch
• Weight: 3050 Pound
• Height: 73.2 Inch
• Length: 105 Inch
• Width: 46 Inch
• Weight: 3050 Pound
• Height: 73.2 Inch
• Length: 105 Inch
• Width: 46 Inch
• Weight: 3050 Pound
• Height: 73.2 Inch
• Length: 105 Inch
• Width: 46 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852678007085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990927

FDA Product Code

• CBF: Chamber, Hyperbaric

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-01

On-Brand Devices [Perry Sigma Monoplace]

• 00852678007115: HYPERBARIC SYSTEM, SIGMA 40 ELITE WITH UNDERCARRIAGE
• 00852678007108: HYPERBARIC SYSTEM, 34" MONOPLACE CHAMBER WITH UNDERCARRIAGE
• 00852678007092: HYPERBARIC SYSTEM, 36" MONOPLACE CHAMBER WITH UNDERCARRIAGE
• 00852678007085: HYPERBARIC SYSTEM, 40" MONOPLACE CHAMBER WITH UNDERCARRIAGE
• 00852678007061: HYPERBARIC SYSTEM, 40" ELITE MONOPLACE CHAMBER
• 00852678007054: HYPERBARIC SYSTEM, 36" ELITE MONOPLACE CHAMBER
• 00852678007047: HYPERBARIC SYSTEM, 34" ELITE MONOPLACE CHAMBER
• 00852678007030: HYPERBARIC SYSTEM, 40" MONOPLACE CHAMBER
• 00852678007023: HYPERBARIC SYSTEM, 36" MONOPLACE CHAMBER
• 00852678007016: HYPERBARIC SYSTEM, 34" MONOPLACE CHAMBER