FDA.report

Bard® Baker Jejunostomy Catheter

Primary DI
00801741075681
Brand
Bard® Baker Jejunostomy Catheter
Company
C. R. Bard, Inc.
Model
0042510
Catalog number
0042510
Device description
Bard® Baker Jejunostomy Catheter
Published
2016-07-28
Public version status
Update
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
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00801741075681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741075681008017410756818017410756810801741075681

GMDN Terms

TermDefinition
Gastric lavage kitA collection of non-sterile devices intended to be used for the manual irrigation, washing, and evacuation of debris (toxic substances) from the stomach. It typically consists of supply/drain bags with lavage and ancillary tubing; activated charcoal may be included. The tubing is intended to be inserted into the nose or mouth of the patient to contact the gastric mucosa where fluids are introduced and removed using gravity. The device is typically used by healthcare providers in clinics and emergency/trauma departments. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge16French
Length108Inch

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
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
true
No natural rubber latex
false
Sterilization required before use
false

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