FDA.report

RTMED

Primary DI
06971642800263
Brand
RTMED
Company
Shandong Haidike Medical Products Co., Ltd.
Model
70mm×100mm
Published
2022-12-07
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
true

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
06971642800263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06971642800263069716428002636971642800263

GMDN Terms

TermDefinition
Cold/cool therapy gelA non-sterile, jelly-like substance in a container or in patch/strip form intended for localized topical skin application to provide a cooling effect for underlying muscles/joints to reduce pain and swelling typically from sports injuries or to reduce pain from tension headache/migraine (cold therapy), and/or for cooling at the skin surface to treat heat rash or sooth irritation (cool therapy). After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
550402542
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06971642801390RTMED2/0 75cm Reverse Cutting 3/8 26mm2024-02-22
06971642801413RTMED2/0 75cm Cutting 3/8 30mm2024-02-22
06971642804285RTMED2 Without Needle 150cm2024-02-22
06971642804292RTMED6/0 Without Needle 150cm2024-02-22
06971642804308RTMED5/0 75cm Cutting 3/8 16mm2024-02-22
06971642804315RTMED5/0 75cm Round Bodied 1/2 13mm2024-02-22
06971642804322RTMED5/0 Without Needle 150cm2024-02-22
06971642804346RTMED4/0 75cm Reverse Cutting 3/8 19mm2024-02-22
06971642804353RTMED4/0 75cm Round Bodied 1/2 16mm2024-02-22
06971642804360RTMED4/0 Without Needle 150cm2024-02-22
06971642804377RTMED3/0 75cm Reverse Cutting 3/8 19mm2024-02-22
06971642804384RTMED3/0 75cm Cutting 3/8 24mm2024-02-22
06971642804391RTMED3/0 75cm Reverse Cutting 3/8 26mm2024-02-22
06971642804407RTMED3/0 75cm Cutting 3/8 30mm2024-02-22
06971642804414RTMED3/0 75cm Round Bodied 1/2 30mm2024-02-22
06971642804421RTMED3/0 Without Needle 150cm2024-02-22
06971642801420RTMED2/0 75cm Round Bodied 1/2 24mm2024-02-23
06971642801437RTMED2/0 75cm Round Bodied 1/2 35mm2024-02-23
06971642801444RTMED2/0 Without Needle 150cm2024-02-23
06971642801451RTMED0 75cm Reverse Cutting 3/8 37mm2024-02-23

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