FDA.reportPublic FDA data

Valu-Tote

Primary DI
00812594011962
Brand
Valu-Tote
Company
NEOTECH PRODUCTS, INC.
Model
10812594011969
Catalog number
A507
Device description
Telemetry Transmitter Holder
Published
2021-06-14
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
true

Product Codes#

Code, Name table
CodeName
JAYSupport, Breathing Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812594011969PrimaryGS10
00812594011962Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081259401196910812594011969
00812594011962008125940119628125940119620812594011962

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, single-useA patient-worn, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
198013435
Device count
100
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812594011405Little Sucker Cover10812594011402N2152022-05-23
00812594010330NeoBond10812594010337N7412021-06-15
00812594011603NeoBond10812594011600N7422021-06-15
00812594012198EZCare Softouch - Pink10812594012195N9106PK2021-06-15
00812594012204EZCare Softouch - Pink10812594012201N9107PK2021-06-15
00812594012211EZCare Softouch - Pink00812594012211N9108PK2021-06-15
00812594012228EZCare Softouch - Pink10812594012225N9109PK2021-06-15
00812594012235EZCare Softouch - Pink10812594012232N9110PK2021-06-15
00812594012242EZCare Softouch - Pink10812594012249N9111PK2021-06-15
00812594012259EZCare Softouch - Tan10812594012256N9105TN2021-06-15
00812594012266EZCare Softouch - Tan10812594012263N9106TN2021-06-15
00812594012273EZCare Softouch - Tan10812594012270N9107TN2021-06-15
00812594012280EZCare Softouch - Tan10812594012287N9108TN2021-06-15
00812594012297EZCare Softouch - Tan10812594012294N9109TN2021-06-15
00812594012303EZCare Softouch - Tan10812594012300N9110TN2021-06-15
00812594012310EZCare Softouch - Tan10812594012317N9111TN2021-06-15
00812594012334EZCare Softouch - Blue10812594012331N9106BL2021-06-15
00812594012341EZCare Softouch - Blue10812594012348N9107BL2021-06-15
00812594012358EZCare Softouch - Blue10812594012355N9108BL2021-06-15
00812594012372EZCare Softouch - Blue10812594012379N9110BL2021-06-15

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