FDA.report

Aqua Plus Bulk Red

Primary DI
G599103R0
Company
Jkr Laboratories, Inc.
Model
103R
Catalog number
103R
Device description
2x250 ml Red
Published
2025-02-07
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
false

Related Records

Regulatory Flags

DUNS number
196376339
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
G599103R0PrimaryHIBCC0

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
G599103R0PrimaryHIBCC0

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
EWDProtector, Hearing (Insert)UUnknownNEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Earmould impression materialA rubber-like material used to replicate the shape of an individual's ear canal for the manufacture of custom-made hearing aids and earmoulds. The device may be supplied as a two-component silicone (base and catalyst) which produces the usable product. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
G599103B0Aqua Plus Bulk Blue103B103B2025-02-07
G5991030Aqua Plus Kit1032024-02-12
G599103D0Aqua Plus Single Red 2x8 g103D2024-02-12
G599103E0Aqua Plus Single Blue 2x8 g103E2024-02-12
G599107A1Blue Ultra Cartridge 8x50 ml107A2024-02-12
G599107C1Pink Ultra II Cartridge 8x50 ml107C2024-02-12
G5991080Gold Velvet II Impression Single 2x8 g1082024-02-12
G599970Gold Velvet II 10 unit972024-02-12
G59997A0Gold Velvet II 40 unit97A2024-02-12
G59997B0Gold Velvet II 80 unit 97B2024-02-12
G599980XL-300 Impression 660 g982024-02-12
G59998A0XL-300 Accelerator 25 g98A2024-02-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10311917079599WalgreensWALGREEN CO.EWD2026-02-19
00033732100786Mack'sMcKeon Products, Inc.EWD2025-08-05
00033732107129Mack'sMcKeon Products, Inc.EWD2025-08-05
00033732107181Mack'sMcKeon Products, Inc.EWD2025-08-05
G599103B0Aqua Plus Bulk BlueJkr Laboratories, Inc.EWD2025-02-07
EDET033491aquaplus colormix yellow 8 x 50 ml DETAX GmbHEWD2024-08-28
EDET033501aquaplus colormix green8 x 50 ml DETAX GmbHEWD2024-08-28
EDET033541aquaplus colormix orange 8 x 50 ml DETAX GmbHEWD2024-08-28
EDET041661bioflex 40 blue 4x50mlDETAX GmbHEWD2024-08-28
EDET041671bioflex 40 rose 4x50mlDETAX GmbHEWD2024-08-28
EDET041681bioflex 40 red 4x50mlDETAX GmbHEWD2024-08-28
EDET041691bioflex 40 transparent 4x50mlDETAX GmbHEWD2024-08-28
30850015055509ULINE REUSABLE EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-25
30850015055516ULINE REUSABLE EARPLUGS - CORDEDULINE, INC.EWD2024-07-25
30850015055523ULINE BULLET EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-23
30850015055530ULINE BULLET EARPLUGS - CORDEDULINE, INC.EWD2024-07-23
30850015055547ULINE BELL EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-23
30850015055554ULINE BELL EARPLUGS - CORDEDULINE, INC.EWD2024-07-23
EDET024231aquaplus colormix red/blue 8 x 50 ml DETAX GmbHEWD2024-05-28
30850015055493ULINE BULLET EARPLUGS REFILLULINE, INC.EWD2024-05-13
00850015055713ULINE EARPLUGS IN A BUCKETULINE, INC.EWD2024-05-13
20057475561035BIOS LivingThermor LtdEWD2024-03-23
20057475561042BIOS LivingThermor LtdEWD2024-03-23
20057475561011BIOS LivingThermor LtdEWD2024-03-22
20057475561028BIOS LivingThermor LtdEWD2024-03-22
20057475561059BIOS LivingThermor LtdEWD2024-03-22
20057475561066BIOS LivingThermor LtdEWD2024-03-22
20057475561073BIOS LivingThermor LtdEWD2024-03-22
20057475561080BIOS LivingThermor LtdEWD2024-03-22
20057475561097BIOS LivingThermor LtdEWD2024-03-22