FDA.report

COLDPACK 11" X 14" (IF NOT AVAIL USE 32186)

Primary DI
00733657225082
Brand
COLDPACK 11" X 14" (IF NOT AVAIL USE 32186)
Company
ALIMED, INC.
Model
32705
Published
2022-12-01
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
false

Related Records

Contact Domains

Product Codes

CodeName
IMEPack, hot or cold, reusable

Product Code Classifications

CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00733657225082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00733657225082007336572250827336572250820733657225082

GMDN Terms

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

Contacts

PhoneEmail
+1(781)329-2900customerservice@alimed.com

Regulatory Flags

DUNS number
056007248
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00733657301038ATEC KIT 4 STRAPS96114529700181532024-08-02
00733657288667ATEC STRAP 2 X 84IN 2 CLOSURE PELVIC LONG96119629700182042024-08-02
00733657288674ATEC STRAP 2 X 72IN 2 CLOSURE PELVIC SHORT96119729700182052024-08-02
00733657288681ATEC STRAP 2 X 42IN 2 CLOSURE THORACIC96119829700182062024-08-02
00733657230253CUSH DROP AWAY POMMEL 16X168892429700113712022-12-15
00733657230260DROP AWAY POMMEL CUSHION 18X168892529700113722022-12-15
00733657240054CATH LAB IMMOBILIZER93189829700134112022-12-15
00733657245035STRAP UNIVERSAL UNIBODY, 5WX65L9-93129700188652022-12-15
00733657283594STRAP UNIVERSAL 3IN X 72IN 10/PK75361029700099892022-12-15
00733657283600STRAP UNIVERSAL 3IN X 72IN 25/PK62575362529700099912022-12-15
00733657283624STRAP UNIVERSAL 4IN x 72IN 10/PK75391029700099962022-12-15
00733657283631STRAP UNIVERSAL 4IN x 72IN 25/PK75392529700099982022-12-15
00733657283648STRAP UNIVERSAL 4IN x 72IN 50/PK75395029700099992022-12-15
00733657283662STRAP UNIVERSAL 4IN x 72IN 100/PK753910029700099972022-12-15
00733657290684ROLLER FOAM FULL ROLL 36" LONG X 6" WIDE ALIMED 3/CS31716032022-12-01
00656204000201HARNESS PAVLIK TYPE51968/NA/LG2022-12-01
00656204000218HARNESS PAVLIK TYPE51968/NA/MD2022-12-01
00656204000225HARNESS PAVLIK TYPE51968/NA/SM2022-12-01
00656204000232HARNESS PAVLIK TYPE51968/NA/XL2022-12-01
00656204004940AFO CHILD LEFT66132/NA/LL2022-12-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00197998026140Solventum™Solventum US LLCIME2026-02-15
00197998026171Solventum™Solventum US LLCIME2026-02-15
00197998026621Solventum™Solventum US LLCIME2026-02-15
00197998320255Solventum™Solventum US LLCIME2026-02-15
00810178881840Arctic FlexVIVE HEALTH LLCIME2026-02-05
00818323024869Arctic FlexVIVE HEALTH LLCIME2026-02-03
00885914107898Sammons PrestonPerformance Health Supply, LLCIME2026-01-23
06973641884206CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884213CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884220CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884237CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884244CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884251CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884268CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884275CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884282CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884299CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884305CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884312CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884329CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884336CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884343CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884350CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884367CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884374CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884381CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884398CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884404CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884411CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884428CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22