FDA.report

ASP MEDICAL

Primary DI
00840216102705
Brand
ASP MEDICAL
Company
Asp Global, LLC
Model
RGPA610SL
Device description
SLEEVE, NON-WOVEN, WHITE, FOR REUSABLE 6X10 HOT/COLD GEL PACK, 2000 EACH BULK CASE
Published
2022-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IMDPack, Hot Or Cold, Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840216102705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216102705008402161027058402161027050840216102705

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

Regulatory Flags

DUNS number
080361159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840216128262ASP GLOBALEGT3052025-11-20
00840216128286ASP GLOBALEGT3072025-11-20
00840216128804ASP GLOBAL PRIMOAFTS012025-06-30
00840216128279ASP GLOBALEGT3062025-06-17
00840216128293ASP GLOBALEGT3082025-06-17
00840216128842CARDINAL HEALTH AD6X10BILH2025-06-17
00840216128606LAPCORP LC4X6EZQ2025-05-13
00840216128613LAPCORP LC9X12MTL2025-05-13
00840216128163QUEST DIAGNOSTICSQD6.75X11AD2024-11-22
00840216127753ASP MEDICALMRT8002024-09-12
00840216128033ASP MEDICALMRACUP12024-09-12
20840216127566PRIMOAFTMATT2024-08-12
00840216120808PRIMOGGS3660TBH-K2024-03-05
00840216120853PRIMOGGS5670TBH-K2024-03-05
00840216121898PRIMOGGTS142024-03-05
00840216124509PRIMOGGTS13-K2024-03-05
00840216124516PRIMOGGTS14-5-K2024-03-05
00840216122697PRIMOAFPUMP2024-03-01
00840216125124PRIMOHB2002024-03-01
00840216125131PRIMOHB200B2024-03-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00080196732343MEDLINEMEDLINE INDUSTRIES, INC.IMD2026-03-19
00850073571903American Hospital SupplyAmerican Hospital Supply LLCIMD2026-03-10
08806109102551Madeca Summer Aroma PatchDongkook Pharmaceutical Co.,Ltd.IMD2026-02-19
08806109102568Madeca Summer Aroma PatchDongkook Pharmaceutical Co.,Ltd.IMD2026-02-19
00885914107966Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914107973Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914107980Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914107997Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108000Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108017Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108024Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108031Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
00885914108055Sammons PrestonPerformance Health Supply, LLCIMD2026-01-23
30665973032611DukalDukal LLCIMD2025-10-31
30665973032628DukalDukal LLCIMD2025-10-31
30860013591930Vpod EliteCool Comforts Co.IMD2025-09-24
40080196733737MEDLINEMEDLINE INDUSTRIES, INC.IMD2025-09-12
20888277659664MEDLINEMEDLINE INDUSTRIES, INC.IMD2025-09-12
00850056748490FORWARD HEAT - Life GuardINTEGRATED MEDCRAFT LLCIMD2025-09-02
40080196733362MEDLINEMEDLINE INDUSTRIES, INC.IMD2025-08-26
10860010472146Instant Cold Pack 6inx9inMedzah IndustriesIMD2025-08-11
20860012637410Instant Cold Pack 4.75x7Medzah IndustriesIMD2025-08-11
20860012637427Non-Woven Instant Cold Packs 5in x 7.5inMedzah IndustriesIMD2025-08-11
20860011917483MEDZAH INSTANT HOT PACKMedzah IndustriesIMD2025-07-30
20860012637403MEDZAH INSTANT HOT PACKMedzah IndustriesIMD2025-07-30
00850073571125American Hospital SupplyAmerican Hospital Supply LLCIMD2025-07-28
00850073571071American Hospital SupplyAmerican Hospital Supply LLCIMD2025-07-09
00840456203828JMUJMU DENTAL, INCIMD2025-06-13
16977244725048HetaidaLinqing HeTaiDa Medical Technology Co., LtdIMD2025-05-12
30860013591909VpodCool Comforts Co.IMD2025-05-02