FDA.reportPublic FDA data

NeoSeal®

Primary DI
10812594011594
Brand
NeoSeal®
Company
Neotech Products LLC
Model
Small
Catalog number
N421
Device description
The NeoSeal is intended to create a seal around the nares and protect the skin of the septum and nares. It is intended for use on pediatric (neonates, infants and children) patients.
Published
2021-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10812594011594PrimaryGS10
00812594011597Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081259401159410812594011594
00812594011597008125940115978125940115970812594011597

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.

Regulatory Flags#

DUNS number
198013435
Device count
150
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812594010177NeoBridge®MicoN7002021-05-19
10812594010269NeoBridge®SmallN7012021-05-19
10812594010276NeoBridge®LargeN7022021-05-19
10812594010351EZ-Hold®StandardN7572021-05-19
10812594010726NeoGrip®BlueN602B2021-05-19
10812594010740NeoGrip®Pink & BlueN6022021-05-19
10812594010764NeoGrip®VersaGrip - LargeN6012021-05-19
10812594010788NeoGrip®WhiteN6032021-05-19
10812594011037Hold-A-Line™StandardN7052021-06-02
10812594011358EZ-Hold®MiniN7562021-05-19
10812594011952Telemetry TotesClip-ToteA5012021-06-14
10812594011969Telemetry TotesValu-ToteA5072021-06-14
10812594012096EZ-Hold®Extra LargeN7582021-05-19
10812594012102NeoGrip®RedN602R2021-05-19
10812594012119NeoGrip®Neon GreenN602G2021-05-19
10812594012126NeoGrip®YellowN602Y2021-05-19
10812594012133NeoGrip®OrangeN602O2021-05-19
10812594012140NeoGrip®VioletN602V2021-05-19
10812594012461NeoGrip®PinkN602P2021-05-19
20812594012925NeoSnug Small20812594012925N7015-152023-09-08

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 / Pediatric Dynarex 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