AccessGUDID - DEVICE: Currie Medical (10817357020950)

GUDID

Device Identifier (DI) Information

Brand Name: Currie Medical
Version or Model: ALP 2 L
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HYGIA HEALTH SERVICES, INC.

Primary DI Number: 10817357020950
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 177939027 *Terms of Use

Device Description: Currie ALP LARGE CALF garment (up to 24" calf circumference)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61809	Single-chamber venous compression system garment, reprocessed	A non-sterile, inflatable device in the form of a stocking, sleeve, or suit intended to be applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the intermittent inflation of a single-chamber. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a previously used single-use device that has been processed for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOW	Sleeve, Limb, Compressible

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053575	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dd077510-0b85-4693-b861-3605837ffdd5
Public Version Date: March 19, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2016