ALP® 500002

GUDID 00857910006000

ALP 1 CALF-R - Garment (Calf, Adult)

CURRIE MEDICAL SPECIALTIES INC.

Single-chamber venous compression system garment, single-use
Primary Device ID00857910006000
NIH Device Record Key07ee31ce-74f8-4174-8ce4-4f1d0a5bd1f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameALP®
Version Model NumberALP® 1 CALF-R
Catalog Number500002
Company DUNS079598595
Company NameCURRIE MEDICAL SPECIALTIES INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857910006000 [Primary]
GS100857910006505 [Package]
Package: Case 10 Pr [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOWSleeve, Limb, Compressible

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-05
Device Publish Date2019-07-26

On-Brand Devices [ALP®]

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

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