FDA.report

Catheter and Glove Suction Kit

Primary DI
10801741050692
Brand
Catheter and Glove Suction Kit
Company
C. R. Bard, Inc.
Model
0140100
Catalog number
0140100
Device description
Catheter and Glove Suction Kit
Published
2020-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL

Product Code Classifications

CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741050692PackageGS150In Commercial Distribution
00801741050695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174105069210801741050692
00801741050695008017410506958017410506950801741050695

GMDN Terms

TermDefinition
Airway suction catheterA flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.

Device Sizes

TypeValueUnit
Length18Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags

DUNS number
016898496
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
No natural rubber latex
false
Sterilization required before use
false

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10801741122146Bard® Robinson Catheter003746000374602016-07-23
10801741122153Bard® Robinson Catheter003748000374802016-07-23

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