FDA.reportPublic FDA data

Cervos Blood Draw Kit 15

Primary DI
10850023741421
Brand
Cervos Blood Draw Kit 15
Company
RANFAC CORP.
Model
CER-BD-15
Catalog number
CER-BD-15
Device description
Cervos Blood Draw Kit 15 F/G, Sterile PN: 76122-01M
Published
2022-01-10
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDDKit, Surgical Instrument, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850023741421PackageGS115In Commercial Distribution
00850023741424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002374142110850023741421
00850023741424008500237414248500237414240850023741424

GMDN Terms#

Term, Definition table
TermDefinition
Non-fixed blood collection needleA sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid excessive heat. Protect from freezing. Protect from direct sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5085884400info@ranfac.com

Regulatory Flags#

DUNS number
121622872
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850023741226Cervos Flex Bone Marrow Aspiration Needle8 Gauge x 9.1cmCER-FLEX2021-07-16
00850023741462CER-LA11 GA X 16.5 CMCER-LA2021-11-10
00850023741479CER-FLEX8 GA X 9.1 CMCER-FLEX2021-11-10
00858690006808Cervos Lipo Pro Double PackCER-LP-40CER-LP-402022-09-19
00850023741561CERVOS PLATELET SEPARATOR 80 KITCER-PRP-80CER-PRP-802026-03-30
00850075308088CER-PRP-160 STERILITY PACKCER-PRP-160-SCER-PRP-160-S2026-03-30
00850075308101CER-PRP-160 KitCER-PRP-160CER-PRP-1602026-03-30
00850075308163CER-PRP-40 KIT F/G, STERILECER-PRP-40CER-PRP-402026-03-30
M9797405001M0NDL, RBN-114, STERILE, F/G"11 GAUGE x 4"""RBN-1142017-05-08
M9797405003M0NDL, RBN-133, STERILE, F/G"13 GAUGE x 3"""RBN-1332017-05-08
M9797405005M0NDL, RBN-132"13 GAUGE x 2"""RBN-1322017-05-08
M9797405006M0NDL, RBN-84, STERILE, F/G"8 GAUGE x 4"""RBN-842017-05-08
M9797405001M9NDL, RBN-114, STERILE, F/G11 GAUGE x 4"RBN-1142017-05-08
M9797405003M9NDL, RBN-133, STERILE, F/G13 GAUGE x 3"RBN-1332017-05-08
M9797405005M9NDL, RBN-13213 GAUGE x 2"RBN-1322017-05-08
00850075308095CER-PRP-SINGLE-ACER-PRP-SINGLE-ACER-PRP-SINGLE-A2025-10-08
00850075308019HYDRACELL-ORTHO-511 Gauge x 6.1CM 5ccHYDRA-ORTHO-52025-09-25
00850075308033HYDRACELL-ORTHO-1011 Gauge x 6.1CM 10ccHYDRA-ORTHO-102025-09-25
00850075308040HYDRACELL-EXT-511 Gauge x 6.3 CM 5ccHYDRA-EXT-52025-09-25
00850075308064HYDRACELL-EXT-1011 Gauge x 6.3 CM 10ccHYDRA-EXT-102025-09-25

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Primary DI, Brand, Company table
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00749756400442DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-21
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08906039319729OSSEOUS Myringotomy Kit-StandardEON MEDITECH PRIVATE LIMITEDKDD2024-07-04
08906039319736OSSEOUS Myringotomy Kit-Pediatric EON MEDITECH PRIVATE LIMITEDKDD2024-07-04
10192253065442Aero-MedAERO-MED, LLCKDD2024-03-11
00811870037979Manus Medical, LLCManus Medical, LLCKDD2024-02-06
10195327271626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327271770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327273293Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
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10195327277680Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327278243Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10193489447897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327264192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327265762Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266271Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-03-05
10195327271633Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-12-18
10885380194108Aero-MedAERO-MED, LLCKDD2022-12-15