FDA.report

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

Related Records

Product Codes

CodeName
BXJClip, Nose

Product Code Classifications

CodeDeviceSpecialtyClass
BXJClip, NoseAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10812594012171PrimaryGS10
00812594012174Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081259401217110812594012171
00812594012174008125940121748125940121740812594012174

GMDN Terms

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

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

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