FDA.report

AMC

Primary DI
00849593000000
Brand
AMC
Company
AMC
Model
AC-6X924/CCL
Device description
Disp Cl Ft Poly Telepouch,24" Top String,Clip,Velcro Lock
Published
2019-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Product Code Classifications

CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00849593000000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849593000000008495930000008495930000000849593000000

GMDN Terms

TermDefinition
Personal device holder, single-useA patient-worn, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080242300
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00084959302521GoldSelect™DGE-602022-11-18
00849593005746LifeSyncLS-2282022-11-20
20849593005764LifeSyncLS-2292022-11-20
00849593005784LifeSyncLS-228D2022-11-20
20849593005801LifeSyncLS-229D2022-11-20
00849593025140GoldSelect™DE-0037602022-11-20
00849593025157GoldSelect™DE-0037102022-11-20
00849593025164GoldSelect™DE-003748-252022-11-20
00849593025171GoldSelect™DE-003760-252022-11-20
00849593025188GoldSelect™DE-003772-252022-11-20
00849593025195GoldSelect™DE-003748-VA2022-11-18
00849593025201GoldSelect™DGE-482022-11-18
00849593025225GoldSelect™DGE-722022-11-18
00849593025232GoldSelect™DGE-1202022-11-18
00849593025249GoldSelect™DE-0037482022-11-18
00849593004138AMCCB-73331R2022-10-17
00849593031998AMCLW-3090024/5A2022-10-17
00849593025041LifeSyncAB 1000 (S)CB-AB 1000-0 (S)2022-10-03

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