FDA.report

CAP SYSTEM 10 (10-PK)

Primary DI
00810080611399
Brand
CAP SYSTEM 10 (10-PK)
Company
MPS Pharma & Medical, Inc.
Model
PF-N10-10
Published
2022-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KYXDispenser, Liquid Medication

Product Code Classifications

CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810080611399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810080611399008100806113998100806113990810080611399

GMDN Terms

TermDefinition
Eye dropper bottleA sterile device intended to store and dispense in drops an eye irrigation solution typically to flush the eye of irritating particulates/chemicals, or to treat a specific eye condition. It does not contain eye irrigation solution. It consists of a small bottle with a nozzle which acts as a dropper spout. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
117970217
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10810080612492OptiDropper®, SafeFill™UA15-415-50-TRAY-102025-08-19
10810080612485OptiDropper®UA15-415-50-BOT-10BRW2025-08-15
10810080612461OptiDropper®UA15-415-108-TRAY-72025-07-19
10810080612379OptiDropper™ AC211633-122025-05-13
10810080612324OptiDropper™AC211631-22025-05-12
10810080612331OptiDropper™ AC211631-3002025-05-12
10810080612348OptiDropper™ AC211632-12025-05-12
10810080612355OptiDropper™AC211632-122025-05-12
10810080612362OptiDropper™AC211633-12025-05-12
10810080612386OptiDropper™AC211633-25R2025-05-12
10810080612393OptiDropper™ AC211633-12BLU2025-05-12
10810080612409OptiDropper™ AC211634-12025-05-12
10810080612416OptiDropper™ AC211634-122025-05-12
10810080612423OptiDropper™ AC211635-12025-05-12
10810080612430OptiDropper™ AC211635-122025-05-12
10810110921389Mini Transfer PinIM271272025-04-28
10810080612447DROPPER BOTTLE SYSTEM UA15-415-56-BOT-52025-04-24
10810080612454DROPPER BOTTLE SYSTEMUA15-415-50-BOT-52025-04-24
10810080612478SAFEFILL™UA15-415-50-TRAY-102025-04-15
00810080612310OptiDropper™ AC211631-122025-02-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00813360023639DoselogixTEAM TECHNOLOGIES, INC.KYX2026-03-24
80827989007853Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007846Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007860Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007877Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007884Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007891Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
00810126506351Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506368Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506375Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506382Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506399Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506405Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506412Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506429Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506436Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506443Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506450Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00194346098088EquateWAL-MART STORES, INC.KYX2025-11-14
04046955861132Exadoral®B. BRAUN MEDICAL INC.KYX2025-09-08
04046955861170Exadoral®B. BRAUN MEDICAL INC.KYX2025-09-08
04046955861217Exadoral®B. BRAUN MEDICAL INC.KYX2025-09-08
10810080612492OptiDropper®, SafeFill™MPS Pharma & Medical, Inc.KYX2025-08-19
10810080612485OptiDropper®MPS Pharma & Medical, Inc.KYX2025-08-15
00813360023189DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
00813360023196DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
00813360023202DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
00813360023219DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
10810080612461OptiDropper®MPS Pharma & Medical, Inc.KYX2025-07-19
00813360023240DoselogixTEAM TECHNOLOGIES, INC.KYX2025-06-05