FDA.report

Hydra

Primary DI
00191506038892
Brand
Hydra
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00501910
Catalog number
M00501910
Device description
Hydra Air/Water Bottle Cap Extended CO2
Published
2024-10-07
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
false

Related Records

Product Codes

CodeName
FEQPUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
FEQPump, Air, Non-Manual, For EndoscopeGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191506038892PackageGS115In Commercial Distribution
00191506038885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506038892001915060388921915060388920191506038892
00191506038885001915060388851915060388850191506038885

GMDN Terms

TermDefinition
Endoscopic insufflation tubing set, reusableA collection of flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
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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