Invacare Spree 3G Pediatric Tilt in Space Wheelchair SPREE3G

GUDID 00841447103028

Invacare Spree 3G Pediatric Tilt in Space Wheelchair

INVACARE CORPORATION

Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

• Primary Device ID: 00841447103028
• NIH Device Record Key: 35c20042-384a-4b47-987c-99c6ab6294fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invacare Spree 3G Pediatric Tilt in Space Wheelchair
• Version Model Number: SPREE3G
• Catalog Number: SPREE3G
• Company DUNS: 076916246
• Company Name: INVACARE 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(440)329-6000
• Email: orders@invacare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841447103028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012370

FDA Product Code

• IOR: Wheelchair, mechanical

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: 2019-06-18
• Device Publish Date: 2019-06-10

Devices Manufactured by INVACARE CORPORATION

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• 00841447114918 - POS STRAP 23-24W HOOK/LOOP: 2024-08-02 Hook & Loop Seat/Chest Positioning Strap (24" Seat Width)
• 00841447114925 - ADJ REAR ANTI-TIPPER (6): 2024-08-02 Invacare Adjustable Rear Anti-Tippers for 6" Casters
• 00841447114932 - IV-OXYGEN HOLDER PACKAGE ASBLY: 2024-08-02 Invacare IV/Oxygen Holder Assembly
• 00841447114949 - KIT ARMPAD FULL W/2 SCREWS CLR: 2024-08-02 Arm Pad w/ screws, Full-Length (13")
• 00841447114956 - KIT ARMPAD DESK W/2 SCREWS CLR: 2024-08-02 Arm Pad w/ screws, Desk-Length (9")
• 00841447114963 - WHEEL LOCK EXTENSIONS 6 IN: 2024-08-02 Invacare 6" Wheel Lock Extensions w/ Bungee Cord
• 00841447114970 - HEMI SMT ART LGRST COMP FTPLT FOR 16-24W: 2024-08-02 Swing-Away Hemi Smartleg Articulating Legrests, Composite Footplates, Padded Calf Pads