FDA.reportPublic FDA data

VIVE

Primary DI
10810041981438
Brand
VIVE
Company
VIVE HEALTH LLC
Model
RHB2008
Device description
Warming Mitten
Published
2020-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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
10810041981438PackageGS11In Commercial Distribution
00810041981431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198143810810041981438
00810041981431008100419814318100419814310810041981431

GMDN Terms#

Term, Definition table
TermDefinition
Utility gloveA device intended to be worn on he hands of a person who needs to protect their hands from potentially adverse effects such as heat, cold, pressure, or contamination during the handling of medical equipment and/or waste. It is typically made of fabric material and used by healthcare personnel. This device is not intended to protect from extreme cold (e.g., cryogenic temperatures). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810178889723ViveSUP3158BLKXS2026-05-27
00810178889730ViveSUP3158BLKS2026-05-27
00810178889747ViveSUP3158BLKM2026-05-27
00810178889754ViveSUP3158BLKL2026-05-27
00810178889761ViveSUP3158BLKXL2026-05-27
00810178889778ViveSUP3159BLKXS2026-05-27
00810178889785ViveSUP3159BLKS2026-05-27
00810178889792ViveSUP3159BLKM2026-05-27
00810178889808ViveSUP3159BLKL2026-05-27
00810178889815ViveSUP3159BLKXL2026-05-27
00810178889822ViveSUP3160BLKXS2026-05-27
00810178889839ViveSUP3160BLKS2026-05-27
00810178889846ViveSUP3160BLKM2026-05-27
00810178889853ViveSUP3160BLKL2026-05-27
00810178889860ViveSUP3160BLKXL2026-05-27
00810178889877ViveSUP3161BLKXS2026-05-27
00810178889884ViveSUP3161BLKS2026-05-27
00810178889891ViveSUP3161BLKM2026-05-27
00810178889907ViveSUP3161BLKL2026-05-27
00810178889914ViveSUP3161BLKXL2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178885954Arctic FlexVIVE HEALTH LLCIME2026-05-06
00840397513215Sharper ImageMerchsource, LLCIME2026-04-23
307073870439893M™3M COMPANYIME2026-04-21
307073870439963M™3M COMPANYIME2026-04-21
10735282287845MunchkinMUNCHKIN, INC.IME2026-03-18
00197998026133Solventum™Solventum US LLCIME2026-02-15
00197998026164Solventum™Solventum US LLCIME2026-02-15
00197998026614Solventum™Solventum US LLCIME2026-02-15
00810178884735ViveVIVE HEALTH LLCIME2025-12-05
00810113683065ManaEZ ROM Ice ShortManamed, Inc.IME2025-10-17
00810113683515ManaEZ Hip Ice CureTechManamed, Inc.IME2025-10-03
00810113683522ManaEZ ROM Ice CureTechManamed, Inc.IME2025-10-03
00810113683539ManaEZ Shoulder Ice CureTechManamed, Inc.IME2025-10-03
00810113683638Cold Compression Wrap, Pro-Ankle WrapManamed, Inc.IME2025-09-26
00810113683645Cold Compression Wrap, Pro-Back WrapManamed, Inc.IME2025-09-26
00810113683652Cold Compression Wrap, Pro-Elbow WrapManamed, Inc.IME2025-09-26
00810113683669Cold Compression Wrap, Pro-Hip WrapManamed, Inc.IME2025-09-26
00810113683676Cold Compression Wrap, Pro-Knee WrapManamed, Inc.IME2025-09-26
00810113683683Cold Compression Wrap, Pro-Shoulder WrapManamed, Inc.IME2025-09-26
00810113683706Cold Compression Wrap, Pro-Ankle Wrap-WLManamed, Inc.IME2025-09-26
00810113683713Cold Compression Wrap, Pro-Shoulder Wrap-WLManamed, Inc.IME2025-09-26
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
00850073571101American Hospital SupplyAmerican Hospital Supply LLCIME2025-07-28
00850073571118American Hospital SupplyAmerican Hospital Supply LLCIME2025-07-28
00627394040018Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00627394040056Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00627394040063Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00810178880300Arctic FlexVIVE HEALTH LLCIME2025-04-04