FDA.report

HUDSON RCI

Primary DI
34026704640486
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN049875
Catalog number
15920
Device description
Universal Mask Harness
Published
2019-04-23
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

Contact Domains

Product Codes

CodeName
BTKSTRAP, HEAD, GAS MASK

Product Code Classifications

CodeDeviceSpecialtyClass
BTKStrap, Head, Gas MaskAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704640486PackageGS150In Commercial Distribution
04026704580545PreviousGS10
14026704640482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670464048634026704640486
04026704580545040267045805454026704580545
1402670464048214026704640482

GMDN Terms

TermDefinition
Anaesthesia mask strap, single-useA non-sterile, non-latex strap/head harness intended to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and affixed to the mask. It is typically used for anaesthesia of long duration. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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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