FDA.reportPublic FDA data

NeoPulse Small

Primary DI
00812594011481
Brand
NeoPulse Small
Company
NEOTECH PRODUCTS, INC.
Model
10812594011488
Catalog number
N781
Device description
Pulse Oximeter Wrap (Qty. 100)
Published
2021-05-19
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
FQMBandage, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812594011488PrimaryGS10
00812594011481Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081259401148810812594011488
00812594011481008125940114818125940114810812594011481

GMDN Terms#

Term, Definition table
TermDefinition
Cable/lead holderA device intended to hold medical cables/leads, primarily those that convey electricity and electrical signals. It is typically used in conjunction with an electrocardiograph (ECG) or an electromyograph (EMG) to support and stabilize electrical cable/leads used during patient treatment. It is typically designed as a jointed, adjustable arm with a mounting fixture, that attaches to the recording device, and a holder at the distal end to hold the cables/leads near the patient; it is intended to help organize and protect the cables/leads to prolong their life and help prevent patient disconnection. This is a reusable 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
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809302580645New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580676New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580911New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580867New Soosung Elastic Bandagesoosung medicalFQM2025-12-24
08809302587217Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587224Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587231Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587248Soosung Elastic Bandagesoosung medicalFQM2025-12-11
10080196571925MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-10-20
10192253065282CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065299CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065305CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065312CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10080196278237MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196691159MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745593MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745630MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745647MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745722MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745739MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10192253049251DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049268DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049275DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049282DermaceaCardinal Health 200, LLCFQM2025-07-21
10080196990733MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-06-10
10080196789207MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-06-02
10080196823536MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-30
10080196692378MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-29
10080196823543MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-29
10097604110577Tronex International, Inc.TRONEX INTERNATIONAL, INC.FQM2025-05-05