FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer

Primary DI
00848253003641
Brand
InHealth Technologies; Blom-Singer
Company
Freudenberg Medical, LLC
Model
PK 2107
Device description
Post-Operative Care Kit with 12/55 Tube & EasyFlow HME
Published
2019-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYDCondenser, Heat And Moisture (Artificial Nose)
CBHDevice, Fixation, Tracheal Tube
EWLProsthesis, Laryngeal (Taub)
KACTube, Laryngectomy
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1
CBHDevice, Fixation, Tracheal TubeAnesthesiology1
EWLProsthesis, Laryngeal (Taub)Ear, Nose, Throat2
KACTube, LaryngectomyEar, Nose, Throat1
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848253003641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848253003641008482530036418482530036410848253003641

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostoma shower shieldA non-sterile, waterproof, patient-worn device intended to cover a tracheal stoma or tracheostomy tube to prevent inhalation of water during showering. It is typically in the form of a waterproof bib worn around the patient’s neck. This is a reusable device intended for single-patient use.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
120981337
Device count
1
Kit
true
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
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
00848253003931TruFit™ Adhesive Housing, 30 PackBE 60882025-04-01

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Primary DI, Brand, Company table
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06979191882273BadBuddyWAL-MART STORES, INC.KGX2026-07-31
06979191883591OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883607OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883690EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883706EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883713EQUATEWAL-MART STORES, INC.KGX2026-07-31
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