APEX

GUDID 14713025000124

iCH Sense

APEX MEDICAL CORP.

Home CPAP unit

• Primary Device ID: 14713025000124
• NIH Device Record Key: 35c3266f-c4d0-4001-bbfd-fa1af2c3a205
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APEX
• Version Model Number: 9S-007001
• Company DUNS: 656413127
• Company Name: APEX MEDICAL CORP.
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04713025000127 [Primary]
GS1	14713025000124 [Package]; Contains: 04713025000127; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150111

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [APEX]

• 04716872506873: CPAP tubing
• 14713025004382: Serene Elite with 8" Mattress
• 04713025004378: Serene Elite Pump
• 14713025004368: Serene Bariatric with 8"+2" Mattress
• 14713025004351: Domus 3 with 5"+3" Mattress
• 04713025004347: 5"+3" Mattress
• 14713025004337: Domus 3 with 8" Mattress
• 04713025003845: 3.5" Cushion
• 04713025003364: 8"+2" Mattress
• 04713025003159: Combo 100 Plus with 4" Cushion
• 04713025003142: Combo 100 Plus Pump
• 14713025003132: Sedens 500 Dynamics with 4" Cushion
• 04713025003128: 4" Cushion
• 04713025003111: Sedens 500 Dynamics Pump
• 04713025003104: Domus 2s Pump
• 14713025002807: Serene with 8"+2" Mattress
• 04713025002725: 8"+2" Mattress
• 04713025002664: Serene Pump,Serene Bariatric Pump
• 04713025002572: Domus 4 with 8" Mattress
• 04713025002565: 8" Mattress
• 04713025002497: 5" One Piece Pad
• 14713025002487: Domus 2s with 5" One Piece Pad
• 04713025002473: Domus Auto with 8" Mattress
• 04713025002435: 9P-077520 Domus Auto
• 04713025002428: FM668005_8"*90cm
• 04713025002404: 9P-077000 Domus 4
• 04713025002213: Domus 3 Pump
• 14713025002050: Domus 1 with 2.5" Bubble Pad
• 04713025002046: Domus 1 Pump
• 04713025002022: 2.5" Bubble Pad
• 04713025000752: Nasal Mask Fitting Kit (XS,S,M,L)
• 14713025000742: Full Face Fitting Kits (SW,MW,LW)
• 04713025000738: Full Face Fitting Kit (S,M,L)
• 14713025000728: Full Face Mask w/o Headgear (LW)
• 04713025000714: Full Face Mask w/o Headgear (MW)
• 14713025000704: Full Face Mask w/o Headgear (SW)
• 04713025000691: Full Face Mask w/o Headgear (L)
• 04713025000684: Full Face Mask w/o Headgear (M)
• 04713025000677: Full Face Mask w/o Headgear (S)
• 04713025000660: Nasal Mask w/o Headgear (L)
• 04713025000653: Nasal Mask w/o Headgear (M)
• 04713025000646: Nasal Mask w/o Headgear (S)
• 14713025000636: Nasal Mask w/o Headgear (XS)
• 04713025000622: Nasal Pillows Mask with Headgear (Ms.: XS,S,M)
• 14713025000612: Nasal Pillows Mask with Headgear (Mr.: S, M, L)
• 14713025000605: Full Face Mask with Headgear (SW)
• 04713025000592: Full Face Mask with Headgear (MW)
• 04713025000585: Full Face Mask with Headgear (LW)
• 14713025000575: Full Face Mask with Headgear (S)
• 14713025000568: Full Face Mask with Headgear (M)