Rocket

Primary DI
05055270964106
Brand
Rocket
Company
ROCKET MEDICAL PLC
Model
R54544-12-00
Catalog number
R54544-12-00
Device description
Rocket 12Fg Seldinger Chest Drainage Kit
Published
2017-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055270964106PackageGS110In Commercial Distribution
05055270921314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055270964106050552709641065055270964106
05055270921314050552709213145055270921314

GMDN Terms#

Term, Definition table
TermDefinition
Pneumothorax catheter insertion setA collection of devices used to puncture the chest wall to enable insertion of a dedicated catheter for the aspiration of a simple pneumothorax or decompression of a tension pneumothorax. It typically consists of a scalpel to make a stab incision and a needle to assist the entry of the catheter with obturator assembly (to protect the internal organs upon entry). Once the catheter is in place, the needle is retracted to allow the flow of air/fluid from within the chest cavity. The set may contain suture for the attachment of the catheter to the skin. It is typically used for accident and emergency (A&E) situations (immediate care or chest crush injury). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Length30Centimeter

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
544313588
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055270911643RocketR29662R296622023-11-03
05055270957245RocketR57616-16-00R57616-16-002023-11-03
05055270988188RocketR53086R530862023-11-03
05055270911612RocketR29658R296582023-10-31
05055270966155RocketR57422-VIPR57422-VIP2023-10-31
05055270974457RocketR57424-VIPR57424-VIP2023-10-31
05055270978868RocketR57603-00-90R57603-00-902023-10-31
05055270984296RocketR57525-00-T2R57525-00-T22023-10-31
05055270984524RocketR29656R296562023-10-31
05055270909060RocketR28135R281352023-10-30
05055270909329RocketR28410R284102023-10-30
05055270984463RocketR28406R284062023-10-30
05055270911575RocketR29654R296542023-10-24
05055270911582RocketR29655R296552023-10-24
05055270911629RocketR29660R296602023-10-24
05055270911636RocketR29661R296612023-10-24
05055270977137RocketR57008-00-FMR57008-00-FM2023-10-24
05055270977168RocketR57008-00-CNR57008-00-CN2023-10-24
05055270979322RocketR56215-MR56215-M2023-10-24
05055270979643RocketR57686R576862023-10-24