APEX

GUDID 04713025007607

Optima Auto

Wellell Inc.

Alternating-pressure bed mattress system

• Primary Device ID: 04713025007607
• NIH Device Record Key: dc1191b9-d786-4cac-b0b4-2e562634eb41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APEX
• Version Model Number: 9P-086020
• Company DUNS: 656413127
• Company Name: Wellell Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04713025007607 [Primary]

FDA Product Code

• FNM: Mattress, Air Flotation, Alternating Pressure

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: 2024-08-23
• Device Publish Date: 2024-08-15

On-Brand Devices [APEX]

• 04719893349290: Sedens 500
• 04719893348781: Sedens 400
• 04719893348606: Procare Elite
• 04719893348583: Procare Elite
• 04719893348552: Procare Elite
• 04719893347999: WiZARD 320 Full Face Mask(S)
• 04719893347982: WiZARD 320 Full Face Mask(M)
• 04719893347791: Serene Air
• 04719893347753: Serene Air
• 04719893347616: Serene Air
• 04719893347593: Serene Air
• 04719893347579: Serene Air
• 04719893347548: Serene Air
• 04719893347340: WiZARD 510 Nasal Mask M Size
• 04719893347333: WiZARD 510 Nasal Mask L Size
• 04719893347302: WiZARD 510 Nasal Mask( M/L)
• 04719893346954: Optima Turn
• 04719893334272: WiZARD 310 Nasal Mask(S)
• 04719893334265: WiZARD 310 Nasal Mask(M)
• 04719893334258: WiZARD 310 Nasal Mask(L)
• 04719893334173: WiZARD 320 Full Face Mask(S)
• 04719893334166: WiZARD 320 Full Face Mask(M)
• 04719893334159: WiZARD 320 Full Face Mask(L)
• 04719893333091: XT Auto (9S-005720)
• 04719893332810: iCH Auto
• 04719893312201: ACS Series Pump and Mattress
• 04716872506637: WiZARD 210 Nasal Mask (XS) (SM01011)
• 04716872506620: WiZARD 210 Nasal Mask (S) (SM01010)
• 04716872506613: WiZARD 210 Nasal Mask (M) (SM01009)
• 04716872506606: WiZARD 210 Nasal Mask (L) (SM01008)
• 04716872505913: WiZARD 220 Full Face Mask (S) (SM02012)
• 04716872505906: WiZARD 220 Full Face Mask (M) (SM02011)
• 04716872505890: WiZARD 220 Full Face Mask (L) (SM02010)
• 04716872505647: XT Heated Humidifier (9S-006500)
• 04713025007607: Optima Auto
• 04713025005597: PRO-CARE Series Pump and Mattress
• 04713025000998: WiZARD 510 Nasal Mask( M/L)
• 04713025000981: WiZARD 320 Full Face Mask(S/M/L)
• 04713025000974: WiZARD 310 Nasal Mask(S/M/L)