FDA.report

Typenex Airway Tape

Primary DI
10810050853450
Brand
Typenex Airway Tape
Company
TYPENEX MEDICAL LLC
Model
AT0101
Device description
Airway Tape
Published
2021-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CBHDevice, Fixation, Tracheal Tube

Product Code Classifications

CodeDeviceSpecialtyClass
CBHDevice, Fixation, Tracheal TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810050853450PackageGS12100In Commercial Distribution
00810050853453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005085345010810050853450
00810050853453008100508534538100508534530810050853453

GMDN Terms

TermDefinition
Multi-purpose surgical skin adhesive tapeA long thin band of synthetic material coated on one side with a pressure-sensitive adhesive, intended to be used for a variety of surgical/clinical intervention external taping applications [e.g., draping a patient for surgery and /or creating a window around a site of intervention, creating a sterile barrier, fixing/sealing items to a patient (e.g., a stockinette), managing/organizing tubing, cables, and other operating room (OR) devices]. It is typically made of a plastic material or combination of materials. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
866-897-3639mchoquette@typenex.com

Regulatory Flags

DUNS number
600850213
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00810050855815ThermoFlo®60612026-01-26
10810050855805Typenex Introducer SetMS2335S2025-11-17
10810050855782Fibernex Laser SystemLS02012025-07-28
20810050855772Microscope SlidesLC0104B2025-07-14
20810050855765Microscope SlidesPS0204W2025-07-08
20810050855741Microscope SlidesPS0404WXT2025-06-17
20810050855758Microscope SlidesPS0404YXT2025-06-17
00810050855457Rad ControlRT03022025-05-23
00810050855471Rad ControlRT03012025-05-23
20810050855697Microscope SldiesLC01012025-02-03
20810050855703Microscope SlidesLC02032025-02-03
20810050855710Microscope SlidesLC01042025-02-03
20810050855727Microscope Slides LC01032025-02-03
20810050855734Microscope SlidesPS0202WXL2025-02-03
20810050855680Microscope SlidesPS0404W2025-01-21
00810050855631ThermoFlo®62412024-12-06
10810050855669ThermoFlo®60012024-11-20
20810050855673Microscope SlidesPS0201WXL2024-11-18

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