ALP® 500010

GUDID 00857910006543

ALP® 2 CALF-XL - Garment (Calf, Adult)

CURRIE MEDICAL SPECIALTIES INC.

Single-chamber venous compression system garment, single-use

• Primary Device ID: 00857910006543
• NIH Device Record Key: 054dc912-3117-48c8-8fc0-2c1469114617
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALP®
• Version Model Number: ALP® 2 CALF-XL
• Catalog Number: 500010
• Company DUNS: 079598595
• Company Name: CURRIE MEDICAL SPECIALTIES INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857910006048 [Primary]
GS1	00857910006543 [Package]; Contains: 00857910006048; Package: Case 10 Pr [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955853

FDA Product Code

• JOW: Sleeve, Limb, Compressible

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: 2019-08-05
• Device Publish Date: 2019-07-26

On-Brand Devices [ALP®]

• 00857910006451: ALP® VasQcare 531 Pump
• 00857910006413: ALP® 521 - Pump (Hospital)
• 00857910006406: ALP® 501 - Pump (Hospital)
• 00857910006154: ALP 1H - Garment (Take-Home, Calf, Adult) packaged in pairs as a consumable part of the VasQcare
• 00857910006635: MS/PVA ALP®1 - Garment (Foot, Adult)
• 00857910006611: ALP® 3 SM THIGH - Garment (Thigh, Adult)
• 00857910006604: ALP® 4 THIGH-L - Garment (Thigh, Adult)
• 00857910006598: ALP® 3 THIGH-R - Garment (Thigh, Adult)
• 00857910006581: ALP® 1P - Garment (Calf, Pediatric)
• 00857910006079: ALP® 1PS - Garment (Calf, Pediatric)
• 00857910006567: ALP® 2 CALF XXL - Garment (Calf, Adult)
• 00857910006055: ALP 1 CALF-S - Garment (Calf, Adult)
• 00857910006543: ALP® 2 CALF-XL - Garment (Calf, Adult)
• 00857910006529: ALP® 2 CALF-L - Garment (Calf, Adult)
• 00857910006512: ALP 1A CALF-R - Garment (Calf, Adult)
• 00857910006000: ALP 1 CALF-R - Garment (Calf, Adult)