Patient Safe®

Primary DI
00613703530028
Brand
Patient Safe®
Company
RETRACTABLE TECHNOLOGIES, INC.
Model
53001
Catalog number
53001
Device description
30mL Patient Safe® Syringe
Published
2016-09-22
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#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072654000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072654000PATIENT SAFE SYRINGERetractable Technologies, Inc.2007-12-14FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613703530011PackageGS140In Commercial Distribution
00613703530028PackageGS14In Commercial Distribution
00613703530004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613703530011006137035300116137035300110613703530011
00613703530028006137035300286137035300280613703530028
00613703530004006137035300046137035300040613703530004

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-703-1010rtiservice@vanishpoint.com

Regulatory Flags#

DUNS number
838024255
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
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
00613703101303VanishPoint®10131101312016-09-22
00613703101501VanishPoint®10151101512016-09-22
00613703102102VanishPoint®10211102112016-09-22
00613703102300VanishPoint®10231102312016-09-22
00613703102508VanishPoint®10251102512016-09-22
00613703102706VanishPoint®10271102712016-09-22
00613703102805VanishPoint®10281102812016-09-22
00613703102904VanishPoint®10291102912016-09-22
00613703152206VanishPoint®15221152212016-09-22
00613703152701VanishPoint®15271152712016-09-22
00613703152909VanishPoint®15291152912016-09-22
00613703153708VanishPoint®15371153712018-04-27
00613703153906VanishPoint®15391153912018-04-27
00613703312204VanishPoint®31221312212016-09-22
00613703313300VanishPoint®31331313312016-09-22
00613703314406VanishPoint®31441314412016-09-22
00613703315403VanishPoint®31541315412016-09-22
00613703316400VanishPoint®31641316412016-09-22
00613703317407VanishPoint®31741317412016-09-22
00613703352200VanishPoint®35221352212016-09-22

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