FDA.reportPublic FDA data

Green Sprouts

Primary DI
00715418088563
Brand
Green Sprouts
Company
O2cool, LLC
Model
379300-201-00
Device description
Cool Calm Press-Pink-Adult use only
Published
2021-06-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IMEPack, Hot Or Cold, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00715418088563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00715418088563007154180885637154180885630715418088563

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, reusableA non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004603413
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00715418071640Green Sprouts379300-300-002021-06-01
00715418071657Green Sprouts379300-500-002021-06-01
00715418094045Green Sprouts379300-916-002021-06-01
00715418020358Green Sprouts222341-920-332223412016-08-23
00715418028590Green Sprouts222340-287-332017-04-12
00715418091136Green Sprouts222392-905-332223922016-09-15
00715418091143Green Sprouts222392-906-332223922016-09-15
00715418046464Green Sprouts309302-523-222021-06-01
00715418077291Green Sprouts242342-907-332021-06-01
00715418092843Green Sprouts22391-907-332021-06-01
00715418093314Green Sprouts222392-920-332021-06-01
00715418127620Green Sprouts264305-907-342021-06-01
00715418128023Green Sprouts221040-920-342021-06-01
00715418130095Green Sprouts221040-575-342021-06-01
00715418130101Green Sprouts221040-676-342021-06-01
00715418130118Green Sprouts221040-274-342021-06-01
00715418147208Green Sprouts385301-400-332021-06-01
00715418154688Green Sprouts385632-001-332021-06-01
00715418155333Green Sprouts758391-000-012021-06-01
00715418155340Green Sprouts758391-000-032021-06-01

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Primary DI, Brand, Company table
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00810113683720Cold Compression Wrap, Pro-Knee Wrap-WLManamed, Inc.IME2025-09-26
00810113683737Cold Compression Wrap, Pro-Hip Wrap-WLManamed, Inc.IME2025-09-26
00810113683744Cold Compression Wrap, Pro-Back Wrap-WLManamed, Inc.IME2025-09-26
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00810178880300Arctic FlexVIVE HEALTH LLCIME2025-04-04