FDA.reportPublic FDA data

Cramer Instant Cold Pack

Primary DI
00311960410304
Brand
Cramer Instant Cold Pack
Company
CRAMER PRODUCTS, INC.
Model
033101
Device description
Pack, Hot or Cold, Disposable
Published
2018-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
IMDPack, Hot Or Cold, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10311960410301PackageGS14In Commercial Distribution
20311960410308PackageGS14In Commercial Distribution
00311960410304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1031196041030110311960410301
2031196041030820311960410308
00311960410304003119604103043119604103040311960410304

GMDN Terms#

Term, Definition table
TermDefinition
Endothermic cold therapy packA device intended to be applied with pressure to the body surface to provide cold therapy to help reduce fever, pain, and inflammation associated with joint/muscle/tissue injury and/or minor burns. It typically consists of a compact envelope made of plastic and filled with chemicals that generate an endothermic chemical reaction when activated to reduce the temperature of the pack. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height9Inch
Width6Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007138183
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20311960752019Cramer All Sports Athletic Tape Pink Zebra 7627202018-09-19
00311960001397Cramer Athletic Tape 7628202018-10-02
00311960001403Cramer Athletic Tape 2pk Blister, White7628252018-10-02
00311960002226Cramer Super Stretch Non-tear Tape2842302018-09-27
00311960002233Cramer Super Stretch Non-tear Tape2843302018-09-27
00311960548588Cramer 950 Athletic Trainer's Tape2820502018-09-25
00311960686037Cramer 950 Athletic Trainer's Tape2821012018-09-25
00311960686044Cramer 950 Athletic Trainer's Tape2821022018-09-25
00311960686228Cramer Athletic Tape 6pk, White7628262018-10-02
00311960686235Cramer 750 Athletic 6 Pack Tape - Black7628212018-10-02
00311960708302Cramer Blister Foam0309072018-10-01
00311960708319Cramer Blister Foam0309082018-10-01
00311960751636Cramer All Sports Athletic Tape 7627002018-09-19
00311960751643Cramer All Sports Athletic Tape 7627012018-09-19
00311960751650Cramer All Sports Athletic Tape 7627022018-09-21
00311960751667Cramer All Sports Athletic Tape 7627032018-09-21
00311960751674Cramer All Sports AthleticTape 7627042018-09-21
00311960751681Cramer All Sports Athletic Tape 7627052018-09-21
00311960751698Cramer All Sports Athletic Tape 7627062018-09-21
00311960751704Cramer All Sports Athletic Tape Retail blister, white7627072018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08436587170010ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170027ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
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08436587170232ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170249ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
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08436587170577ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
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08436587170843ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170867ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170942ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170966ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170973ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171017ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171031ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171208ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171253ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171284ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171314ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171338ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171352ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15