FDA.reportPublic FDA data

SAF-Q

Primary DI
10817708020554
Brand
SAF-Q
Company
EMED TECHNOLOGIES CORPORATION
Model
SAF-Q-106-G24-Q10
Catalog number
SAF-Q-106-G24-Q10
Device description
"36"" Single SUB-Q set with safety, 6mm needle and 24-gauge w/Dressing, Box of 10"
Published
2020-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140131000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140131000SUB-Q SUBCUTANEOUS TISSUE INFUSION SETEmed Technologies Corporation2014-04-03FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817708020554PrimaryGS10
00817708020557Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081770802055410817708020554
00817708020557008177080205578177080205570817708020557

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical infusion pump administration setA collection of devices intended to be used with a mechanical infusion pump (non-electric) to enable the intermittent or continuous infusion of medication (not included), typically for antibiotic therapy, chemotherapy, or pain management [including patient-controlled analgesia (PCA)] by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It typically consists of a reservoir (e.g., a plastic pouch), plastic tubing, a check valve, a line clamp, and Luer connectors. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length6Millimeter
Length36Inch
Needle Gauge24Gauge
Total Volume0.34Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-5 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
(916) 932-0071customerservice@emedtc.com

Regulatory Flags#

DUNS number
622637544
Device count
10
Lot or batch
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
00817708022957Tetra MicroTM-20FP-00102132026-02-24
00817708022971Tetra MicroFP-0010214FP-00102142026-02-24
00817708023374Tetra MicroFP-0010215FP-00102152026-02-24
00817708023428Tetra MicroFP-0010216FP-00102162026-02-24
00817708023435Tetra MicroTM-50FP-00102122026-02-24
00817708023411OPTFlowOPT12609-46Q10OPT12609-46Q102026-01-09
10817708023418OPTFlowOPT12609-46Q10OPT12609-46Q102026-01-09
00817708023381EMED Soluble Hemostatic GauzeEHEM22-10EHEM22-102019-01-30
00817708023398SCIg60FP-00100322020-08-07
00817708020274SCIg60 Infusion SystemFP-0010002FP-00100022016-09-23
10817708020578SAF-QSAF-Q-106-G27-Q10SAF-Q-106-G27-Q102020-12-07
10817708020615SAF-QSAF-Q-106-SNF-Q10SAF-Q-106-SNF-Q102020-12-07
10817708020639SAF-QSAF-Q-109-G24-Q10SAF-Q-109-G24-Q102020-12-07
10817708020677SAF-QSAF-Q-109-G27-Q10SAF-Q-109-G27-Q102020-12-07
10817708020691SAF-QSAF-Q-109-G27-SNF-Q10SAF-Q-109-G27-SNF-Q102020-12-07
10817708020714SAF-QSAF-Q-112-G24-70-Q10SAF-Q-112-G24-70-Q102020-12-07
10817708020738SAF-QSAF-Q-112-G27-Q10SAF-Q-112-G27-Q102020-12-07
10817708021155SUB-QSUB-104-G27-Q10SUB-104-G27-Q102020-12-07
10817708021179SUB-QSUB-106-G27-Q10SUB-106-G27-Q102020-12-07
10817708021193SUB-QSUB-106-G27-70-Q10SUB-106-G27-70-Q102020-12-07

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