FDA.report

T-PIECE, 22F, 22M, 22M WITH ONE-WAY VALVES

Primary DI
05030267005116
Brand
T-PIECE, 22F, 22M, 22M WITH ONE-WAY VALVES
Company
INTERSURGICAL INCORPORATED
Model
1953000
Device description
T-PIECE, 22F, 22M, 22M WITH ONE-WAY VALVES
Published
2021-10-06
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
BZAConnector, Airway (Extension)

Product Code Classifications

CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267005109PackageGS125In Commercial Distribution
05030267005116PackageGS1100In Commercial Distribution
05030267057153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267005109050302670051095030267005109
05030267005116050302670051165030267005116
05030267057153050302670571535030267057153

GMDN Terms

TermDefinition
Non-rebreathing valve, single-useA non-sterile device containing a one-way valve intended to be used to direct the flow of breathing gases, typically in a breathing circuit or between an oxygen mask and its reservoir bag, to prevent patient rebreathing of exhaled gases. The device is available in various designs and includes unidirectional valves made of various materials (e.g., silicone, rubber, metal, or mica sheets/discs) that typically open and close with each inspiration/expiration. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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