FDA.report

CAP SYSTEM 200 (2PK)

Primary DI
00810080611474
Brand
CAP SYSTEM 200 (2PK)
Company
MPS Pharma & Medical, Inc.
Model
PF-N2-200
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
00810080611474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810080611474008100806114748100806114740810080611474

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

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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

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80827989007877Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
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