FDA.report

15mmF / 30mmM Adapter

Primary DI
10841470109971
Brand
15mmF / 30mmM Adapter
Company
PULMODYNE INC
Model
313-8184
Published
2017-12-31
Public version status
Update
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

Product Codes

CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications

CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841470109971PackageGS150In Commercial Distribution
00841470109974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084147010997110841470109971
00841470109974008414701099748414701099740841470109974

GMDN Terms

TermDefinition
Tube/mask breathing circuit connector, single-use, non-sterileA non-sterile device intended to connect a breathing circuit breathing tube to an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with standardized connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excluding Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter15Millimeter
Outer Diameter30Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
030619483
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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