FDA.reportPublic FDA data

NeoSeal Large

Primary DI
00812594012174
Brand
NeoSeal Large
Company
NEOTECH PRODUCTS, INC.
Model
10812594012171
Catalog number
N422
Device description
Nasal Seal CPAP (Qty. 150)
Published
2021-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BXJClip, Nose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXJClip, NoseAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812594012171PrimaryGS10
00812594012174Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081259401217110812594012171
00812594012174008125940121748125940121740812594012174

GMDN Terms#

Term, Definition table
TermDefinition
Patient tube cushionA small patient-worn padding intended to function as a barrier between a patient tube/catheter (e.g., nasogastric tube, oxygen tube, surgical drain, laryngectomy or tracheostomy tube) and the skin to prevent irritation, maceration, and ulceration. It is typically made of a skin-friendly material (e.g., foam, silicone gel) designed to wrap/fit around the tube/catheter. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
198013435
Device count
150
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
05060120956415Nose ClipGVS FILTER TECHNOLOGY UK LTDBXJ2026-02-10
15060120956412Nose ClipGVS FILTER TECHNOLOGY UK LTDBXJ2026-02-10
14250892907007JaegerJaeger Medical GmbHBXJ2025-06-02
14250892907014JaegerJaeger Medical GmbHBXJ2025-06-02
14250892907021JaegerJaeger Medical GmbHBXJ2025-06-02
00816472022545Nose Clip with PaddingIntersurgical IncorporatedBXJ2025-04-14
00816472022552Nose Clip with PaddingIntersurgical IncorporatedBXJ2025-04-14
00817081028287Disposable White PFT Nose Clip with Rubber Pads, Labeled D R BurtonA-M SYSTEMS, LLCBXJ2025-02-25
00817081028300Disposable Blue PFT Nose Clip with Rubber PadsA-M SYSTEMS, LLCBXJ2025-02-25
00817081028324Disposable Blue PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2025-02-25
00817081028294Disposable White PFT Nose Clip with Rubber Pads, Labeled D R BurtonA-M SYSTEMS, LLCBXJ2025-02-25
00817081028317Disposable Blue PFT Nose Clip with Rubber PadsA-M SYSTEMS, LLCBXJ2025-02-25
00817081028331Disposable Blue PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2025-02-25
00817081028201PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2025-02-20
00817081028218PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2025-02-20
00840117322004Resp-O2 PFM Nose Clips, Adult/PediatricDynarex CorporationBXJ2024-10-21
00840117321991Resp-O2 PFM Nose Clips, Adult / Pediatric Dynarex CorporationBXJ2024-10-21
M996NC125850NC 12585 Nose ClipINSTRUMENTATION INDUSTRIES, INCORPORATEDBXJ2024-07-16
00026072012154BFAllied Medical, LLCBXJ2024-05-28
07613365500103NoseclipGanshorn Medizin Electronic GmbHBXJ2023-07-03
00810016250616Medical GraphicsMEDICAL GRAPHICS CORPORATIONBXJ2023-06-14
00817081027495Disposable PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2023-03-16
00817081027501Disposable PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2023-03-16
00810071633614CuraplexBOUND TREE MEDICAL, LLCBXJ2022-12-30
00810071633621CuraplexBOUND TREE MEDICAL, LLCBXJ2022-12-30
00810071633638CuraplexBOUND TREE MEDICAL, LLCBXJ2022-12-30
00810071633645CuraplexBOUND TREE MEDICAL, LLCBXJ2022-12-30
00810071633652CuraplexBOUND TREE MEDICAL, LLCBXJ2022-12-30
00810071633669CuraplexBOUND TREE MEDICAL, LLCBXJ2022-12-30
00817081027396Disposable PFT Nose Clip with Rubber PadsA-M SYSTEMS, LLCBXJ2022-11-15