mBrace 4280 Wrist Support 140-0280-00

GUDID 10815614021085

The mBrace Model 4280 is a wrist support device that extends the patient's wrist at a consistent 30°angle with a syringe clip to attach a syringe. The mBrace Model 4280 has a valley in the area below the wrist to allow a hemostasis device strap to be easily applied.

SEMLER TECHNOLOGIES, INC.

Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use Wrist immobilizer, single-use

• Primary Device ID: 10815614021085
• NIH Device Record Key: f44f27fe-b6fa-4161-819c-8189166cca9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mBrace 4280 Wrist Support
• Version Model Number: 4280
• Catalog Number: 140-0280-00
• Company DUNS: 042075700
• Company Name: SEMLER TECHNOLOGIES, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815614021085 [Primary]
GS1	20815614021082 [Package]; Package: [30 Units]; In Commercial Distribution

FDA Product Code

• FMQ: Restraint, Protective

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: 2024-02-09
• Device Publish Date: 2024-02-01

Devices Manufactured by SEMLER TECHNOLOGIES, INC.

• 10815614021085 - mBrace 4280 Wrist Support: 2024-02-09The mBrace Model 4280 is a wrist support device that extends the patient's wrist at a consistent 30°angle with a syringe clip to attach a syringe. The mBrace Model 4280 has a valley in the area below the wrist to allow a hemostasis device strap to be easily applied.
• 10815614021085 - mBrace 4280 Wrist Support: 2024-02-09 The mBrace Model 4280 is a wrist support device that extends the patient's wrist at a consistent 30°angle with a syringe clip t
• 10815614020187 - CompressAR Large Round Disc: 2023-07-04 The CompressAR Large Round Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compre
• 10815614020194 - CompressAR Large Comfort Disc: 2023-07-04 The CompressAR Large Comfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply comp
• 10815614020217 - CompressAR Jumbo Comfort Disc: 2023-07-04 The CompressAR Jumbo Comfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply comp
• 10815614020224 - CompressAR 3-FingerJack Disc: 2023-07-04 The CompressAR 3-FingerJack Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compr
• 10815614020231 - CompressAR Large SuperComfort Disc: 2023-07-04 The CompressAR Large SuperComfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply
• 10815614020248 - CompressAR Jumbo SuperComfort Disc: 2023-07-04 The CompressAR Jumbo SuperComfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply
• 10815614020255 - ClampEase Disc: 2023-07-04 The ClampEase FAPD-FB Disc is a femoral artery flat tunnel pressure disc with a BALL attach.