FDA.reportPublic FDA data

VWR GeneMate

Primary DI
00850038007135
Brand
VWR GeneMate
Company
NEVS INK, INC.
Model
L-3008-6
Catalog number
490017-976
Device description
1" x 60yd Lead-Free Autoclave Tape
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850038007135PrimaryGS10
00852238007142Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038007135008500380071358500380071350850038007135
00852238007142008522380071428522380071420852238007142

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius38 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-638-7465nevsink@nevsink.com

Regulatory Flags#

DUNS number
604708693
Device count
3
DM exempt
true
Premarket exempt
false
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852238007227VWR76376-47076376-4702020-04-24
00869656000273Nev's Ink, Inc.LFA-GB-050LFA-GB-0502020-04-24
00852238007159VWR GeneMateL-3008-6490017-9762016-09-16
00852238007005VWR89097-92489097-9242016-09-16
00852238007012VWR10142-60210142-6022016-09-16
00852238007029VWR10127-46010127-4602016-09-16
00852238007036VWR10127-46410127-4642016-09-16
00852238007050VWR10127-45810127-4582016-09-16
00852238007074VWR10127-46210127-4622016-09-16
00852238007098VWR GeneMateL-3005-1490019-7682016-09-16
00852238007111VWR GeneMateL-3008-4490017-9722016-09-16
00852238007128VWR GeneMateL-3008-5490017-9742016-09-16
00852238007135VWR GeneMateL-3008-7490017-9782016-09-16
00852238007180Pipette.comCAP-T25-60CAP-25-602017-05-23
00852238007197Pipette.comCAP-T35-60CAP-T35-602017-05-23
00852238007203Pipette.comCAP-T25-47CAP-T25-472017-05-23
00852238007210Pipette.comCAP-T35-47CAP-T35-472017-05-23
00860671000323Nev's Ink Inc.TC-auto-1TC-auto-12016-09-01
00869656000204Nev's Ink Inc.Auto-50Auto-502016-09-01
00869656000211Nev's Ink Inc.Auto-75Auto-752016-09-01

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