AccessGUDID - DEVICE: MyoSleeve (07290020483003)

GUDID

Device Identifier (DI) Information

Brand Name: MyoSleeve
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HL-S-Rt-St
Company Name: ELASTIMED LTD

Primary DI Number: 07290020483003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600461703 *Terms of Use

Device Description: MyoSleeve Half leg, Small, Right, Short

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
63558	Wearable sequential venous compression system	A noninvasive, electrically-powered, entirely patient-worn device assembly intended to improve venous and lymphatic return from the leg to help treat/prevent venous disorders/sequelae (e.g., swelling, pain, thrombosis). It consists of an electronic processor with a compressing mechanism (e.g., pump, contracting straps) intended to be strapped to the calf, which provides a continuous peristaltic wave motion, and used for prescribed periods of treatment. It is normally available [non-prescription] over-the-counter (OTC) for use in the home and/or for hospitalized/institutionalized patients.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOW	Sleeve, Limb, Compressible

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232300	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: ff05b9bc-ca75-4578-851a-c52e452a8dad
Public Version Date: December 30, 2025
Public Version Number: 1
DI Record Publish Date: December 22, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
47290020483001	4	07290020483003	In Commercial Distribution	Carton
27290020483007	2	07290020483003	In Commercial Distribution	Carton
17290020483000	1	07290020483003	In Commercial Distribution	Carton

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(844) 679-9100
Email: support@elastimed.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES