FDA.report

Cath'N Sleeve Suction Kit

Primary DI
10801741050258
Brand
Cath'N Sleeve Suction Kit
Company
C. R. Bard, Inc.
Model
0089340
Catalog number
0089340
Device description
Cath'N Sleeve Suction Kit With Solution Container, CSR Wrap and Two Vinyl Gloves
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
10801741050258PackageGS150In Commercial Distribution
00801741050251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174105025810801741050258
00801741050251008017410502518017410502510801741050251

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
Catheter Gauge14French
Length22Inch

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
false
No natural rubber latex
true
Sterilization required before use
false

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