FDA.reportPublic FDA data

SPRAY / PUMP

Primary DI
00860009716124
Brand
SPRAY / PUMP
Company
Jhk, Inc.
Model
0651, 0681, 0671, 0695, 0661, 0641, 0631
Published
2023-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IFISPRAYS, SYNTHETIC, SMEAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IFISprays, Synthetic, SmearPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009716124PrimaryGS10
00860009716155Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009716124008600097161248600097161240860009716124
00860009716155008600097161558600097161550860009716155

GMDN Terms#

Term, Definition table
TermDefinition
Medication spray bottleAn empty, flexible squeeze-container with a spray nozzle used to deliver medication in an atomized form, e.g., nasal spray. This is a single-use device.

Regulatory Flags#

DUNS number
867236309
Device count
24
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009716162PACK, HOT OR COLD, DISPOSABLE0912, 0922, 0910, 0920, 0925, 09272023-07-28
00860009716100ELASTIC BANDAGE0314, 03932023-07-28
00860009716186TAPE AND BANDAGE, ADHESIVE0505, 0535, 05752023-07-28
00860009716179ELASTIC BANDAGE0314, 03932023-07-28
00860009716117EXTRACTOR, SPLINTER REMOVER15242023-07-28
00860009716155SPRAY / PUMP0651, 0681, 0671, 0695, 0661, 0641, 06312023-07-28
00860009716131SCALPEL, ONE-PIECE1512, 1510, 15152023-07-28
00860009716148GAUZE / SPONGE, NONRESORBABLE FOR EXTERNAL USE0551, 0552, 0553, 0572, 0573, 0802, 0803, 0804, 082023-07-28
00860009716193TAPE AND BANDAGE, ADHESIVE0505, 0535, 05752023-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860177000681DYNAMIC FREEZEECOTEC MANUFACTURING, INC.IFI2025-07-29
00860009716155SPRAY / PUMPJhk, Inc.IFI2023-07-28
00860177000636Max Pro Medical Freeze SprayECOTEC MANUFACTURING, INC.IFI2018-08-15
00852509006027COLD AS ICEECOTEC MANUFACTURING, INC.IFI2017-11-21