Rocket

Primary DI
05055270920898
Brand
Rocket
Company
ROCKET MEDICAL PLC
Model
R54410-16-11
Catalog number
R54410-16-11
Device description
Rocket IPC Split Dilator 16G x 11cm
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123033000ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE BRocket Medical Plc2013-02-01DWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055270942289PackageGS110In Commercial Distribution
05055270963680PackageGS18In Commercial Distribution
05055270920898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055270942289050552709422895055270942289
05055270963680050552709636805055270963680
05055270920898050552709208985055270920898

GMDN Terms#

Term, Definition table
TermDefinition
Pleural drainage system fluid collectorA sterile device that is a component of a pleural drainage system and used for the collection of abnormal fluid accumulation (e.g., effusions) from the pleural cavity. It has an integral three-chambered construction; these are the drainage chamber, the suction control chamber and a water seal (underwater) chamber. It is connected to the patient by means of a thoracic drain tube and a suction system regulator, typically connected to the central vacuum system, provides the suction. It is usually employed to restore normal lung function following chest or mediastinal surgery (open heart surgery) or for medical conditions, e.g., pneumothorax and/or haemothorax. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French
Length11Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure101 KiloPascal101 KiloPascal
Handling Environment Humidity1 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature-5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure101 KiloPascal101 KiloPascal
Storage Environment Humidity1 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+4401914196988gudid@rocketmedical.com

Regulatory Flags#

DUNS number
544313588
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055270982339RocketR54400-00-00R54400-00-002023-10-20
05055270982643RocketR54410-WB-DLR54410-WB-DL2023-10-23
05055270982667RocketR54400-00-RKR54400-00-RK2023-10-23
05055270984289RocketR57525-00-T2R57525-00-T22023-10-31
05055270983237RocketR54549-26-PKR54549-26-PK2023-10-23
05055270913999RocketR57525-00-GER57525-00-GE2016-09-07
05055270914002RocketR57525-00-HR57525-00-H2016-09-07
05055270914019RocketR57525-00-P1R57525-00-P12016-09-07
05055270914026RocketR57525-00-P2R57525-00-P22016-09-07
05055270914033RocketR57525-00-TR57525-00-T2016-09-07
05055270964618RocketR57525-00-EVR57525-00-EV2016-09-07
05055270966025RocketR57525-00-AKR57525-00-AK2016-09-07
05055270966056RocketR57525-00-ALR57525-00-AL2016-09-09
05055270966087RocketR57525-00-E2R57525-00-E22016-09-07
05055270966117RocketR57525-00-GSR57525-00-GS2016-09-07
05055270967466RocketR57525-00-ECR57525-00-EC2016-09-07
05055270971241RocketR57525-00-EDR57525-00-ED2016-09-07
05055270971579RocketR57525-00-ESR57525-00-ES2016-09-07
05055270988546RocketR57525-00-MER57525-00-ME2023-10-24
05055270988638RocketR57525-00-T3R57525-00-T32023-10-24