FDA.report

OXYSEPT

Primary DI
00827444000140
Brand
OXYSEPT
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
93002
Catalog number
93002
Device description
OXYSEPT (ULTRACARE) 12OZ + 36 TABLETS
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LPNAccessories, Soft Lens Products

Product Code Classifications

CodeDeviceSpecialtyClass
LPNAccessories, Soft Lens ProductsOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10827444000147PackageGS16In Commercial Distribution
30827444000141PackageGS14In Commercial Distribution
00827444000140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1082744400014710827444000147
3082744400014130827444000141
00827444000140008274440001408274440001400827444000140

GMDN Terms

TermDefinition
Contact lens protein-removal solutionA formulation of proteolytic enzymes, that may or may not be dissolved in cleaning (and possibly disinfecting) contact lens solution, used to remove debris and protein deposits from reusable contact lenses, or to remove protein deposits only. The lenses are typically soaked for a period in the solution and then rinsed in fresh contact lens cleaning solution for the removal of any residual material. Protein build-up on contact lenses often occurs from tear secretion. After application, this device cannot be reused.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)266-4543JJV-US-EYEHEALTH@ITS.JNJ.COM

Regulatory Flags

DUNS number
103021940
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
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

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05050474806177PURESEE IOLDEN00VDEN00VU0602026-03-16
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05050474806221PURESEE IOLDEN00VDEN00VU0852026-03-16
05050474806238PURESEE IOLDEN00VDEN00VU0902026-03-16
05050474806245PURESEE IOLDEN00VDEN00VU0952026-03-16
05050474806252PURESEE IOLDEN00VDEN00VU1002026-03-16
05050474806269PURESEE IOLDEN00VDEN00VU1052026-03-16
05050474806276PURESEE IOLDEN00VDEN00VU1102026-03-16
05050474806283PURESEE IOLDEN00VDEN00VU1152026-03-16
05050474806290PURESEE IOLDEN00VDEN00VU1202026-03-16
05050474806306PURESEE IOLDEN00VDEN00VU1252026-03-16
05050474806313PURESEE IOLDEN00VDEN00VU1302026-03-16
05050474806320PURESEE IOLDEN00VDEN00VU1352026-03-16
05050474806337PURESEE IOLDEN00VDEN00VU1402026-03-16
05050474806344PURESEE IOLDEN00VDEN00VU1452026-03-16

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