FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer

Primary DI
00848253001753
Brand
InHealth Technologies; Blom-Singer
Company
Freudenberg Medical, LLC
Model
SP 1102
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFBButton, Nasal Septal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFBButton, Nasal SeptalUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848253001753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848253001753008482530017538482530017530848253001753

GMDN Terms#

Term, Definition table
TermDefinition
Nasal septal buttonA device that is implanted to occlude a perforation in the nasal septum. It typically consists of a central post and two flanged ends. The device is inserted into a nostril, one leaf is folded and placed through the septum perforation, grasped through the opposite nostril and secured closing the perforation. It is used to improve nasal respiration.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Not to exceed 66C

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-477-5969InHealth@inhealth.com

Regulatory Flags#

DUNS number
120981337
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848253003634InHealth Technologies; Blom-SingerPK 21062019-07-10
00848253003641InHealth Technologies; Blom-SingerPK 21072019-07-10
00848253003399InHealth Technologies; Blom-SingerPK 21002019-06-07
00848253003405InHealth Technologies; Blom-SingerPK 21012019-06-07
00848253003412InHealth Technologies; Blom-SingerPK 21022019-06-07
00848253003429InHealth Technologies; Blom-SingerPK 21032019-06-07
00848253003436InHealth Technologies; Blom-SingerPK 21042019-06-07
00848253003443InHealth Technologies; Blom-SingerPK 21052019-06-07
00813307012597InHealth Technologies; Blom-SingerBE 60452018-01-01
00813307012603InHealth Technologies; Blom-SingerBE 60462018-01-01
00813307012634InHealth Technologies; Blom-SingerBE 60412018-01-01
00813307012641InHealth Technologies; Blom-SingerBE 60422018-01-01
00813307012658InHealth Technologies; Blom-SingerBE 60432018-01-01
00813307012665InHealth Technologies; Blom-SingerBE 60442018-01-01
00813307012672InHealth Technologies; Blom-SingerBE 60342018-01-01
00813307012689InHealth Technologies; Blom-SingerBE 60352018-01-01
00813307012740InHealth Technologies; Blom-SingerBE 60482016-09-24
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-101PN1007960-1002026-01-29
00848253004037StomaSoft Cleaning SwabsTSWB10TSWB102025-03-17
00848253003955TruFit™ Adhesive Housing, 6 PackBE 6088-62025-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000886721N/AMEDTRONIC XOMED, INC.LFB2025-06-23
00763000886738N/AMEDTRONIC XOMED, INC.LFB2025-06-23
34063107102258Nasal Septal ButtonBoston Medical Products, Inc.LFB2022-09-29
10385640065204SUMMIT MEDICALSUMMIT MEDICAL, INC.LFB2021-06-18
10385640065211SUMMIT MEDICALSUMMIT MEDICAL, INC.LFB2021-06-18
10385640065228SUMMIT MEDICALSUMMIT MEDICAL, INC.LFB2021-06-18
00813307013013InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00813307013082InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002101InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002118InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002125InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002132InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002149InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002156InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002163InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002170InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002187InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002194InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00763000035686N/AMEDTRONIC XOMED, INC.LFB2020-04-19
00763000035693N/AMEDTRONIC XOMED, INC.LFB2020-04-19
00763000036119N/AMEDTRONIC XOMED, INC.LFB2020-04-19
00681490041935NAMEDTRONIC XOMED, INC.LFB2017-03-11
00681490041942NAMEDTRONIC XOMED, INC.LFB2017-03-11
00681490195317NAMEDTRONIC XOMED, INC.LFB2017-03-11
00681490195331NAMEDTRONIC XOMED, INC.LFB2017-03-11
00681490195348NAMEDTRONIC XOMED, INC.LFB2017-03-11
00818501020010Invotec Nasal Septal ButtonINVOTEC INTERNATIONAL, INC.LFB2017-01-03
00818501020003Invotec Nasal Septal ButtonINVOTEC INTERNATIONAL, INC.LFB2016-12-31
00848253001715InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2016-09-24
00848253001722InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2016-09-24